What is change control ? Step by step handling of change control with examples ( Production department)

 In pharmaceutical production, change control is a crucial process that ensures any modifications to equipment, processes, or procedures are managed systematically and safely. Here are some examples of how change control is handled in the pharma industry:

Equipment Change: When a pharmaceutical company decides to replace or upgrade a critical manufacturing equipment, a formal change control process is initiated. It involves assessing the impact of the change, conducting risk assessments, and ensuring proper validation of the new equipment before implementation.

Process Change: If there is a need to modify a manufacturing process, change control is employed to evaluate the potential impact on product quality, safety, and efficacy. This process includes thorough documentation, testing, and validation to ensure the changes do not compromise product quality.

Raw Material Change: When there is a need to switch or modify a raw material used in drug manufacturing, change control is applied to evaluate the impact on the product's quality attributes and regulatory compliance. Any such change must be approved through a formal change control procedure.

Packaging Change: Pharmaceutical products are often subject to changes in packaging materials or design. Change control is employed to assess the impact on product stability, shelf life, and compatibility with the new packaging.

Change in Manufacturing Site: If a company decides to move production from one site to another, extensive change control measures are implemented to ensure the new facility meets regulatory requirements, maintains product quality, and prevents cross-contamination.

In all these examples, the change control process involves a thorough evaluation of potential risks, proper documentation, and adherence to regulatory guidelines to ensure patient safety and product quality are maintained throughout the changes.

The management of change control in pharmaceutical production involves a series of systematic steps to ensure that any modifications to equipment, processes, or procedures are evaluated, documented, and implemented in a controlled manner. Here are the typical steps in the change control process:

Initiation of Change Control Request: The process begins with the identification of a need for change, which could be due to various reasons such as process improvements, equipment upgrades, or regulatory requirements. The individual or department proposing the change initiates a change control request.

Change Proposal and Impact Assessment: A detailed change proposal is prepared, outlining the reasons for the change, its scope, and the intended benefits. An impact assessment is conducted to evaluate potential risks and impacts on product quality, safety, and regulatory compliance.

Change Control Review Board (CCRB): A Change Control Review Board or Committee, composed of cross-functional representatives, reviews the change proposal and impact assessment. The board ensures that all necessary aspects have been considered and evaluates the overall feasibility of the proposed change.

Approval and Authorization: If the Change Control Review Board approves the change, the proposal is formally authorized. The responsible personnel or department is assigned to implement and oversee the change.

Change Implementation Plan: A comprehensive implementation plan is developed, detailing the steps, resources, and timelines required to execute the change. This plan includes risk mitigation strategies and validation requirements.

Validation and Testing: Depending on the nature of the change, validation studies and testing may be conducted to ensure that the modified process or equipment functions as intended and meets the required quality standards.

Documentation and Records: Throughout the change control process, detailed documentation is maintained, including all change-related activities, decisions, and outcomes. This documentation is critical for regulatory compliance and audits.

Training and Communication: All relevant personnel are trained on the changes to ensure proper understanding and adherence to the new procedures. Effective communication is vital to keep all stakeholders informed during the implementation process.

Verification and Monitoring: After the change has been implemented, the process is monitored to ensure it performs as expected. This includes ongoing data collection and analysis to verify that the intended outcomes are achieved.

Closure and Review: Once the change is successfully implemented and verified, the change control process is formally closed. A post-implementation review is conducted to assess the effectiveness of the change and identify any lessons learned for future improvements.

By following these steps, pharmaceutical companies can effectively manage change control in production, ensuring product quality, safety, and compliance are maintained while facilitating continuous improvement in their operations.

Pharmaceutical Packaging, Different types and Benefits of pharmaceutical packaging

 The medical field has been playing an important role in everyone’s life not only in human life but also in the life of other living species. The most important part of the medical field is the “Medicine” and when it comes to medicine, the manufacturing process and the packaging play a very critical role.

So, what is pharmaceutical packaging, how it’s been done, does it have different types, what are the materials used? Well, let’s reach out to all such questions and more.

Whether it’s any other product or medicine, packaging plays an important part in all.  Packaging has often been referred to as the 5th P of the marketing mix. In the case of medicines, the packaging is not just part of the marketing mix but very critically related to the product features, application, and shelf life. The packaging of drugs is important to protect drugs from damage, germs, outer atmosphere, and bacteria and at the same time have to take care of child and old age safety concerns.

Types of Pharmaceutical Packaging:

1. Containers

2. Aluminium foil

3. Injectibles/ Vials

4. Bottles

5. Cartons

6. Paper Board

7. Lamitubes

8. Paper

9. PVC Based Combinations

Packaging in the pharmaceutical industry varies from drug to drug and normally there are three levels of packaging commonly referred to as the primary, secondary, and tertiary packaging.

1. Primary packaging system is the material that first envelops the product and holds it i.e., those package components and subcomponents that actually come in contact with the product, or those that may have a direct effect on the product shelf-life e.g., ampoules and vials, prefilled syringes, IV containers, blister packs, etc.

2. Secondary packaging system is outside the primary packaging and used to group primary packages together e.g., cartons, boxes, shipping containers, injection trays, etc.

3. Tertiary packaging system is used for bulk handling and shipping e.g., barrel, container, edge protectors, etc.

Some commonly used types of primary pharmaceutical packaging are Ampoules, Vials, Blister packs, Bottles, and Sachet packaging. let’s check out each of them in detail.

Ampoules Packaging:

The ampoule packs are mainly taken in use for the packaging of a small number of liquid drugs. These containers are small in size compared to the vials packaging and are mostly used to store single-dose medicines and are made up of glass or plastic materials.

Vials Packaging:

Vial containers are also made of glass and plastic materials but are comparatively larger in size than the ampoules containers. These containers are also used to store liquid, solid, or powder drugs but their capacity to store drugs is more compared to the ampoules containers.

Blister packs:

Blister packs are commonly used for the packaging of solid doses like tablets and capsules & Losenges. The packs are mainly made up of thermoformed plastics and manufactured with the lidding of aluminum foil or plastic that could be torn using hand. A state-of-the-art blister pack usually comprises a basic coat of aluminium or robust paper or plastic and a transparent plastic film through which the individual tablets can then be squeezed one by one.

This has proved cost-effective to produce and also less wasteful than other types of packaging, as it requires relatively little material.

Tablets are easy to remove and to dose, thus contributing to better patient satisfaction.

The transparent film makes it possible to identify a product quickly and to enhance its advertising impact at the POS.

Over the past 40 years, blister packs have been adopted globally by the pharmaceutical industry because of the flexibility in design and high productivity that the process delivers for the packaging of oral solids.

Blister packs act as perfect sealing agents for microbes and provide stable and reliable solutions for pills. Blister packaging material is getting more popular as it provides an aseptic solution

Dosing accuracy reduces all medication errors. Blister packs are gaining popularity owing to their “smart” features; one can track whether the pills are taken on time or not. Nowadays, blister packs are being linked with sensors that send alerts to smartphones, thereby reducing medication errors.

Bottles:

Pharma Pet Bottles

Pharmaceutical packaging bottles are usually available in two types of glass and plastic bottles. They are mostly available in orange and light brown color as these colors protect liquid drugs from ultraviolet lights.

Sachet Packaging:

Sachet packages are small pouch available in different shapes and sizes e.g: square and rectangle shapes. These pouches are mainly made up of a particular type of plastic, gives paper-pouch kind of look to the pouch and could be easily torn by the hand. These pouches are affordable and can only be used once, as once torn couldn’t be reused.

Benefits of Effective Pharmaceutical Packaging:

Nowadays, there has been huge competition in every field. so, the outer look and packaging of the product play an important role, the pharmaceutical packaging is not just about attracting or convincing people to purchase the medicine but a lot more. To keep the drug safe packaging plays a very important role but the most critical aspect is the material used for packaging as the drugs should remain safe during the course of its shelf life and should not react with the material of the containers.

The information and guidance mentioned over the packaging should be mentioned in detail, clear, and readable which would make packaging looking more effective and trustworthy.

The effective packaging of drugs is really important, making drug packaging better not only benefits the patients but also increases the trust of the consumer to the particular brand which would indirectly increase sales.

Corrosion on tablet tooling its effect and remedies

Tablet tooling: Don’t let it corroded

Corrosion can severely affect tablet compression tooling if it is not addressed effectively. It can delay production, reduce efficiency and cause contamination problems.

Corrosion can be detected by the appearance of discoloration, etching or common red rust. The main cause of corrosion is acidic substances, which can include ingredients found within the formulation being compressed and even in the surrounding atmosphere. The iron particles in the metal tooling are exposed to oxygen and moisture in the form of humidity or vapor. When the steel is exposed to water, the iron particles are lost to the water’s acidic electrolytes. This means they oxidize the iron particles, which form corrosion on the punches and dies.

There are several reasons why corrosion can occur, and although challenging, it can be resolved with a combination of the correct steel, coating or treatment selection and proper maintenance procedures.

Atmospheric moisture

One of the principal causes of corrosion is excessive moisture and humidity. This is because corrosion often forms in areas where the liquid is present. Oxygen is found in the air we breathe and humid air carries water. The percentage of water vapor in the air varies based on temperature and can range from as low as 0.2% to up to 4% water vapor.

Excess humidity in the compression room, tool storage area or places where the drug formulation is stored prior to compaction can have a significant impact on corrosion forming on the tooling. It is therefore extremely important to control the environment in all areas of tablet production.

As we cannot remove oxygen from the air and tooling is made from steel, environmental factors should be in place to regulate the temperature and humidity and minimize moisture to prevent corrosion from forming on the punches and dies.

Formulation content

All formulations have very different characteristics with varying moisture content, which is often needed to help bind the tablet structure. However, too much water within the tablet can be a cause of corrosion and lead to other problems like sticking.

It is not just moisture content within the formulation that can lead to corrosion. Formulations containing corrosive elements such as chlorine, salts and acids will react with the tooling surfaces and result in oxidation. In addition, wash-in-place systems fitted to some modern tablet presses expose tooling to water and cleaning solutions. Post-compression cleaning procedures can also cause corrosion if not controlled appropriately. It is therefore important that tooling has the appropriate corrosion-resistant properties through the correct steel and coating selection.

Protecting against moisture

Optimizing the environment in which tablet compression and storage of tooling takes place can have a significant impact on preventing corrosion, but other solutions, including tooling material, coatings and maintenance, should also be considered.

Tool steel selection

Wear and degradation of tooling are inevitable in tablet manufacture. The repetitive cyclic action of compression will take its toll on tooling, particularly if they are not maintained. A substantial influence on tooling deterioration is the formulation being compressed. Some products can cause adverse effects on the punch tips — for example, certain granules are extremely hard and abrasive. These can scratch, wear and impregnate the steel surface. Other granulates can contain corrosive elements which react with the steel. This deterioration can lead to tableting defects like black spots, which are the result of corroded tooling and sticking where the granulation adheres to the punch tip face causing costly wastage, reduced yield and unwanted press downtime.

Although tools are manufactured from hardened and tempered tool steel, the demanding processes involved can lead to deterioration if the tool material is not optimized to suit the formulation being compressed.

High-quality tooling should be able to offer long life and be anti-abrasive and wear-resistant. The appropriate choice of material will help to reduce the risk of damage to the punches and dies from the effects of abrasion, corrosion and impregnation of hard granules.

The correct steel is crucial to the successful performance of tablet compression tooling. There are several characteristics that should be addressed when selecting steel:

Strength: Ability to withstand an applied stress without failure

Corrosion resistance: Resistance to oxidizing, staining and discoloration

Toughness: Resistance to chipping, cracking and punch tip breakage

Abrasive wear resistance: Resistance to abrasive wear of punch tips and die bores

Adhesive wear resistance: Resistance to adhesive wear, galling and welding

Hardness: Resistance to impregnation from hard, sharp granules

Compressive strength: Resistance to die bore ringing and plastic deformation of punch tip edges

Fatigue resistance: Progressive and localized structural damage that occurs when a material is subject to cyclic loading

If the tooling being used is prone to corrosion due to environmental effects or because of the characteristics of the formulation, a specially selected tool steel is a good option. Specialized martensitic stainless steels with high chromium content should be used as they have a higher resistance to oxidization, staining and discoloration of the tablet tooling.

Coatings and treatments

Tool coating selection can have a fundamental impact on production. When used in conjunction with high-quality tooling steel, tool coatings are a great method of solving tablet production problems. They allow for better tableting efficiency and output by reducing the requirement for tools to be taken out of production for additional cleaning and maintenance work to remove problematic residue, which, if left untreated, may cause potential production issues, such as corrosion, sticking and picking.

Traditionally, electro-plated hard chromium was the most popular coating used within the tablet tooling industry, but it has many disadvantages. When hard chromium is applied to tooling, a certain amount of hydrogen penetrates the substrate, which can decrease the steel’s working load by up to 20%. To counter this effect, the plated tools undergo a baking process known as de-embrittlement that reduces but does not eliminate the unwanted characteristic. It is also subject to micro-cracks which can develop during the plating process when the internal stress exceeds the tensile strength of the chromium. These micro-cracks are problematic because they provide a porous route to the substrate that will allow granule or cleaning solutions to attack the steel beneath.

Specialized coatings have been developed which are chromium-rich and applied via an advanced Physical Vapor Deposition (PVD) process. The PVD process creates a very smooth dense anti-stick coating. This process incurs none of the drawbacks associated with applying hard chrome.

When it comes to choosing a tool coating, understanding the product being compressed is crucial. For example, if the formulation has a high number of corrosive elements like salts and acids, it will eventually react with the steel and result in oxidation and other forms of decay. In these instances, an appropriate corrosion-resistant coating should be selected, for example, those containing chromium or chromium nitride.

Tool maintenance

Incorrect tool maintenance procedures including the handling, cleaning, polishing and storage of punches and dies can have a huge impact on tablet production. All these processes will expose the tooling to materials and environments where there is a risk of oxidization. It is therefore important that tried and tested maintenance practices are in place to prolong tool life.

The purpose of regular tablet tooling maintenance is simple: to minimize compression problems and ensure that it operates at its highest functionality. Ensuring tablet punches and dies are kept in optimum condition to produce high-quality tablets is critical for productivity and overall equipment effectiveness (OEE). Frequent audits of procedures should be planned to maintain and protect against corrosion issues. The cost of poor tool care and maintenance not only results in additional unnecessary tool purchases but also in production problems that could have been avoided.tooling is cleaned without corrosion inhibitor or insufficiently dried, corrosion can take place.

The appropriate cleaning procedures are essential when looking to prevent corrosion. It will remove granules from the punch and help to avoid product contamination and potential production issues such as sticking and picking caused by old products adhering to the surface of the punch tip.

Post-cleaning is also the ideal time to accurately assess the condition of the tooling. If punches are not clean, any visual assessment of the punch tips and die bores can be affected. This would mean that problems like wear, damage or corrosion are missed.

When tooling is removed from the tablet press, it must be thoroughly cleaned to remove any oil or product residue, particularly from difficult-to-reach areas such as embossing and keyways. One of the most reliable cleaning methods is ultrasonic cleaning. Ultrasonic baths allow for consistent cleaning results, reduced processing and operator time, and reduced risk of tablet contamination. Importantly, ultrasonic cleaning allows for the whole punch to be cleaned including in and around the embossing. It is essential, however, that the process does not cause corrosion of the tooling material, therefore a corrosion inhibitor should be added to the cleaning cycle at a defined concentration. This will form an oxide film on the surface of the metal, passivating the steel and protecting it from corrosion.

It is also important to remember to thoroughly dry tooling after cleaning to ensure there is no residue of cleaning fluids left on the tooling surface which could cause corrosion.

Appropriate storage is another critical process to consider when preventing corrosion. Tooling can be exposed to moisture if the storage system is not clean and dry. A good storage facility with tooling protected by a layer of non-toxic, FDA compliant oil or grease will help prevent corrosion from forming on the tooling surface. The duration of the tooling storage will determine if oil (short term) or grease (long term) is required.

Handling of the tooling can be another cause for concern. It is always recommended to use gloves when picking up the tooling. This is because acids and moisture are present in human hands and can cause and accelerate corrosion on tooling. It is not unheard of for a rusty fingerprint to be left behind! Ensuring gloves are worn at all times and following proper maintenance procedures and techniques will prevent this from happening.

Adopting a simple structured tooling maintenance process is essential to obtain the maximum life from punches and dies. By applying these recommended best practices problems like corrosion will be prevented and tool life will be extended.

Keep a check on corrosion

The cost of corrosion due to not understanding the characteristics of the formulation and poor tool care and storage not only results in additional unnecessary tool purchases but also in production problems that could have been avoided. It is important to address corrosion at the root cause so tablet production is not affected.

Know the granule being compressed, does it contain hard and abrasive granules or ingredients that contain chlorine, salts and acids? Is there high moisture content in the air where compression and storage take place? If the answer is ‘yes,’ it is important to protect tooling so corrosion does not take hold.

Through the use of the correct tool steel and corrosion-resistant coatings, the durability and efficiency of tablet tooling will increase. Add to this effective maintenance and tool care procedures and pharmaceutical manufacturers can obtain the maximum life from tablet punches and dies.

What is Data integrity and ALCOA plus in pharmaceutical industry

 What is Data Integrity?

Data integrity is the maintenance of, and the assurance of, data accuracy and consistency over its entire life-cycle and is a critical aspect to the design, implementation, and usage of any system that stores, processes, or retrieves data.

Data integrity is a key approach in the pharmaceutical quality control system. ALCOA is (Attributable, Legible, Contemporaneous, Original, and Accurate) was introduced in the 1990s for ensuring the pharma industry as a framework for data integrity and Good documentation practice (GDP). Then further introduced ALCOA plus is (Complete, Consistent, Enduring and Available) Currently used by the FDA, WHO, PIC/S, and GAMP. So overtime periods, data integrity concepts expand from ALCOA to ALCOA plus for ensuring data security and integrity ( data protection) are observed and maintained.

ALCOA+

ALCOA has five basic principles (Attributable, Legible, Contemporaneous, Original, and Accurate) to stop data integrity issues.

Attributable:

The collected data must be attributed, who performs the action and when, if a record is changed, who did it and why? For example, when during conducting of validation, the test result must be dated, and the initial should be done by the person involved in conducting the test. If any change in the monitoring system, the change detail should be in the audit trail and any correction made by the person should be recorded and dated. A signature log must be for the identification of initials and the person who completed the paper record.

Legible:

Legible data means the data can be easily read. This attribute should be ensured both in the short and long term, therefore the materials used in recording and collecting the data should be durable.

Contemporaneous:

The data should be recorded at the time and date of work performed. The timestamp should we follow in order.

For example, when conducting validation protocol, the result of the test performed should be recorded in an online sequence. Recording the results should be dated with a timestamp then logged in the electronic system.

Original:

The information must be recorded as original or in a certified true or original copy; this may be an acceptable protocol or a database or a notebook.

For example validation test is being recorded on a given protocol because recording test results in a Notebook may be a chance of error. If the original data is handwritten, it must be stored in an electronic system.

Accurate

For data and records to be accurate, they should be free from errors, complete, truthful and reflective of the observation. Editing should not be performed without documenting and annotating the amendments.

For example:

• Use a witness check for critical record collection to confirm accuracy of data.
• Consider how to capture data electronically and verify its accuracy. Build accuracy checks into the design of the electronic system.
• Place controls/verification on manual data entry, for example, temperature results can only be entered within a predefined range of 0-100°C.

ALCOA PLUS (+)

Complete:- All data should be complete including, test repeat or re-analysis performed on the sample.

Consistent:-  Consistent in a generation of record and application of date and time stamps in the expected sequence.

Enduring:- Data should be recorded in a controlled worksheet in laboratory notebooks or invalidated Electronic systems.

Procedure for Calibration of Balances in pharmaceutical industry

 MONTHLY CALIBRATION OF BALANCES 

For monthly Calibration of Balances check following parameters-

1. Accuracy - verify the balance with minimum weight (least count × 100), 5%, 20%, 50%, 90% capacity of respective balance capacity.

Tolerance - the variation if any should be ± least count of the balance or ± 0.2% of certified standard weight used whichever is higher 

 2. Reproducibility - 

Check the reproducibility by using minimum standard weight of balance capacity. Place the weight in the middle of the weighing pan observe the displayed value 

Then calculate the %RSD by following formula 

RSD= SD×100 / X 

Where, 

X= mean of the individual value

Acceptance = %RSD should not be more than 2.0%

3. Eccentricity 

Eccentricity is the difference between the weight placed in centre and at peripheral points of the weighing pan 

Basics and use of HVAC system in pharma

HVAC is an essential aspect in pharmaceutical industry as factors like temperature, relative humidity and ventilation have a direct impact on the quality of the pharmaceutical product. The designing of the HVAC should be sorted out while design concept of facility is in progress as it is linked to the architectural layouts like air locks, doorways and lobbies. Once the HVAC system is properly designed and installed it not only helps to create the required room pressure differential cascades but also prevents the cross contamination. Basically an HVAC system works by transferring the heat and moisture into and out of the air and controls the level of the air pollutant either by removing them or diluting them to a particular level.

TECHNOLOGY OVERVIEW:

HVAC system varies according to the size and installation capacity within a facility but the basic components remain almost the same.

LAYOUT OF A TYPICAL BASIC HVAC SYSTEM
HEATING SYSTEM:

The heat source is either a furnace or another popular choice is boilers that heat water for steam radiators, or forced-water systems with baseboard radiators, electric heat, and heat pumps. A furnace will generally operate on natural gas or propane, while a boiler will use gas or oil to heat the water. Furnaces are generally installed with central air conditioners. Heat pumps provide both heating and cooling. Some heating systems have an integrated water heating system. Another option is a hydronic heating system also called as radiant floor. These use piping under a floor, and are made up of flexible tubes that are filled with water or a glycol solution.

COOLING SYSTEM:

The purpose of cooling equipment is to chill the water for pumping to cooling coils. From one end the treated air is then blown over the chilled water coils into the space to be cooled through the ventilation system. As part of the refrigeration cycle in the chiller, heat must also be rejected from the system via a cooling tower or condenser.

DUCT LINES AND VENTILATION:

The ducts are used within the system to circulate both hot and chilled water in the building to the required areas. The stale air is expelled by using a separate duct line. The installation of duct lines is an important part therefore location and  material type is considered at the time of designing of the HVAC system.

THERMOSTAT:

The thermostat (HVAC Controller) is installed to turn equipment on or off and to adjust the chillers and boilers, air and water flow rates, temperature and pressures. This also make the components work efficiently through the means of regulation of required conditions. A controller incorporating one or more temperature sensors inside the workspace sends a signal to the heating or cooling coils to activate.If there is a demand for heating or cooling then the controls may also send a signal to the chiller and boiler to operate as required. There are often other control panels on the chiller or boiler too, allowing users to have greater control.

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Types of granulation in tablet formulation

TYPES OF GRANULATION
Granulation can be achieved by three method as follows :-
1. Direct compression   
      Crystalline substance like sodium chloride, sodium bromide may be compressed directly. The vast majority of medicinal agents are rarely so easy to tablet, direct compression material should posses good flow and compresibility and must be inert, tasteless, able to disintegrate and inexpensive.
Method
(Drug + filler + disintegrant + lubricant + glidant ) all are blend directly after sifting through Viber sifter and compressed


2. Dry Granulation
   It is used in situations where effective dose of a drug is too high for direct compaction and the drug is sensitive to heat, moisture, or both which preclude wet granulation. This is also called slugging method.
Method
A.      (Drug + filler + lubricant) All are.       blend then precompression done and     after that   comminution done
 
 B.  (glidant + lubricant + disintigrant)  sizing then blend with A

3. Wet Granulation
  Wet granulation forms the granules by binding the powders together with an adhesive, instead of by compaction. Liquid bridge are developed between particles, and the tensile strength of these bond increase as the amount of liquid binder added is increased. A drying process is required in all wet granulation to remove the solvent and to reduce the moisture content. After drying granulation is screened again, followed by compression.

Schematic drawing of All types granulation

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WALK IN FOR ACME GENERICS LLP ON 5th AUG 2017

We are looking for Executive/Officers/Operators Position in QA/QC/Production/HR department for our manufacturing facility at North India

Find below detailed advertisement below

Who we are:

A Leading Pharma Group with Global Presence and approvals from EU-GMP, MHRA-UK, ANVISA Brazil, PICS Ukraine, WHO Geneva, INVIMA Colombia, USFDA*

We have 3 facilities in North India and 1 R&D centre at Bengaluru ,

1. Immacule Lifesciences- Manufacturing of Liquid and Lyophillized injections approved from MHRA, ANVISA, PICS Ukraine, USFDA Scheduled

2. Acme Formulation Pvt Ltd- Comprises of 2 blocks (General & Hormone) , manufacturing Tablets, Capsules approved by WHO Geneva

3. Acme Generics LLP - Comprises of 2 blocks (General & Thyroxine) , manufacturing Tablets, Capsules approved by EU-GMP

This position is for

Company Name: Acme Generics

Location: Baddi (Himachal Pradesh) near Chandigarh

Multiple Positions:

Production (Manufacturing) and Packing Operations-Experience in Coating/Granulation/ Compression/ Capsule/Alu- Alu/Blister/ Strip/ areas.

Quality Assurance- Experience in IPQA/QMS/Validation/ Qualification with thorough knowledge of cGMP norms.

Quality Control- Experience in Instrumental and chemical analysis i.e. RM/PM/FG/Validation/Micro/ Stability on instruments like HPLC, GC, UV, IR.

Human Resources- Experience in Recruitment/ Talent Acquisition /Payroll/ Liasoning / Statutory Compliances/Admin Activities.

Designation: Executives/Officers/Operators

Experience: 1- 8 years of experience in Pharmaceutical Industry

Educational Qualification: B. Pharma / M. Pharma / B. Sc / M. Sc / MBA H.R

Salary: Negotiable(Best in Industry)

Interview Venue:

Acme Generics LLP

Plot No. 115, HPSIDC Industrial Area, Davni, Manpura near Baddi (H.P)

Date & Time:

05th August 2017 (Saturday) ,

9:00 am onwards

Ph: 01795-332612-60

Contact: HR Team

hr@acmegenerics.in

Note: Candidates who are able to relocate to Baddi (H.P) and join us immediately can only apply

Interested and eligible candidates are advised to appear for WALK-IN along with updated CV, passport size Photograph and salary supportings.

GOOD DOCUMENTATION PRACTICES

Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.

THE IMPORTANCE OF DOCUMENTATION:

As per GMP "If it is not written down, then it did not happen". The document provides information on when, where, who, why and how to complete the task. The document provides evidence proving that the tasks have been completed as they should be.

BASIC REQUIREMENTS OF GDP:

1. Always record the entries at the time of activity simultaneously.

2. Always record date with signature in GMP records.

3. Always use an indelible ballpoint pen to record data in GMP records.

4. Always enter the data directly in the GMP records in the English language.

5. Never use a pencil or erasable or water-soluble ink pen to complete the GMP records.

6. Never use white ink or correction fluid to correct the entry in GMP records

7. Never sign for someone else on any document. Only sign for the work that you have performed yourself.

8. Never back date GMP records.

9. Never discard original raw data of any kind.

10. Never use scratch papers, loose papers or “post it” to record the data.

11. Never discard or destroy any GMP record unless retention period expiry is reached.

12. Documentation and records used throughout the manufacturing process, as well as supporting

processes, must meet the basic requirement of GDP.

List of such documents is provided below (List is not limited):

Batch records

Bill of Materials

Specifications

SOPs

Protocols

Test methods

Checklists

Forms / Log sheets

Training assessments

Certificate of Analysis

Technology transfer document

Validation documents

Maintenance records

Calibration records

GENERAL REQUIREMENTS

Below mentioned requirements should be applied to all the documentation within the GMP environment.

A. Clearly written documentation:

● All documents must be accurate and written in a manner that prevents errors and ensures consistency. 

● If documents are to be used together, e.g. a SOP and a form, then each should reference the other. 

● Ensure there is traceability between two or more documents/records using formal document numbers or record identification. 

B. Using indelible ink:

● All records must be filled out in indelible BLACK or BLUE ballpoint pen for long term legibility. 

● Do not use pencil or ink that can be erased.

C. Legible handwritten Entries:

● A document is unusable if it cannot be read, so care must be taken to ensure that handwriting is legible. All entries must be made at the time the tasks are performed and should be legibly signed and dated. 

● The same is true for electronic documents and records – language should be clear and unambiguous. 

D. Reviewing and approving:

● To ensure that the information is correct and accurate, documents and records should be reviewed by someone who has performed the task and has proper knowledge. A signature and date by the reviewer/approver confirm that a review has taken place. 

● Unsigned documents or records are incomplete and should not be used to perform any task or considered as evidence of a completed task

E. Employee signatures:

● Handwritten signatures must be unique to the individual and listed within the signature register to ensure that the signature is traceable to the concerned employee (or contractor).

● Any employee should not be permitted to sign for another member of staff unless delegated. Signatures must never be forged.

● The management of the signature record should be governed by a procedure and routinely reviewed so that it remains current – new employee should sign the signature register during induction, the signature register must indicate the date employee exit.

PREPARATION OF DOCUMENTS

1. Clear and concise titles should be used for headings, tables, graphs, etc.

2. Pages in the master document should be numbered as X of Y.

3. Full-text spelling with the abbreviation in brackets should be used for the first time. The abbreviation may be used in place of full-text spelling in the remainder of the document.

4. All documents should have the signature and date of the person who prepared the document, reviewed the document and approved the document.

5. All master documents should have an effective date, approval date, and current version number.

6. Respective SOPs should be followed while preparing the documents.

7. Words that everyone can understand should be used. Unfamiliar words reduce the reader’s understanding of what is written. Definitions of abbreviations should always be included in the document for reference. This is most effectively done by including the definitions in a table format, at the start or end of the document.

8. Ensure that the contents of the document are not squeezed into a smaller area just to limit page numbers. Documents with small margins and no spaces between paragraphs and headings can be difficult to look at, hard and slower to read. Space the contents out so that the type/font is easy to read for all users.

9. When creating a document, consider the context in which the document may be used in the future and whether the reader has enough background information.

10 People remember information best when there is a strong visual prompt, such as a diagram. When the document has to be lengthy, consider using tables to structure the information for the easy understanding of the reader.

11. Training of the document should be planned only after approval of document and shall be completed before the effective date.

ISSUANCE AND RETRIEVAL OF GMP RECORDS

1. All the forms associated with the activity should be part of respective SOPs.

2. QA maintains the list of GMP impacting forms and its associated SOP.

3. Records for issuance and retrieval of such forms should be maintained.

RECORDING THE TIME AND DATE IN GMP RECORDS

1. Time should be entered in 24:00-hour cycle. Record the time in HH: MM format. For Example 11:05 AM should be written as 11:05 and 11:05 PM should be written as 23:05.

2. The date should be entered in DD.MM.YY format. For example, 27th July 2013 should be written as 27.07.13.Place “0” before the digit if the digit is less than 10 for the recording of date.

DATA RECORDING IN THE GMP RECORDS

1. Date and time should be recorded in GMP records as mentioned above.

2. Data should be recorded only in the format duly issued and approved by Quality Assurance.

3. Entries in the logbooks should be made in chronological order. Entries should never be pre-completed.

4. Data recording should be done by trained and authorized person.

5. Data should be recorded as it is displayed on the respective equipment panel.

6. Unusual observation during the activity should be recorded, signed and dated. Same should be reported to area person in-charge and QA.

7. If any observation/signature/date are to be repeated, the same should be rewritten. Ditto (----“---) marking or “as above” or “do” should not be used.

8. Manual entries should be reviewed and signed by the second person for accuracy and completeness.

9. Raw data/print outs generated during the activity should be signed at the left bottom with date and should be attached to relevant records. Printouts made on the thermal paper should be photocopied. Thermal paper copy along with photocopy should be attached to the concerned record.

CORRECTION OF ENTRY IN GMP RECORDS

1. Incorrect entries in GMP records should not be overwritten or blocked to make it unreadable.

Always use a single strike out line (For example: Incorrect Entry) to mark the incorrect entry in such a manner that entry remains readable.

2. Correct entry should be written near to the strikeout entry. Person correcting the entry should put the initial signature and date along with corrected entry. Only the person who made the original entry and strikethrough should make the correction. If this is not possible, notify to QA.

3. The reason for correcting the entry should also be documented on the record. In the case of space constraint in the document, the reason for correction should be mentioned on the footer of the record with (*) sign.

HANDLING OF MISSING ENTRY IN GMP RECORDS

1. Entries in the GMP records should be done contemporaneously with the activity. However, the procedure mentioned below should be followed in the exceptional case of missing entry in GMP records.

2. Missing entry in the GMP records can be re-entered later if the data are retrievable. (For example: start time of blender is missed by the operator, however, the entry for the same is mentioned in the equipment usage log)

3. In such case, an entry should be made with a clear indication of the date when the activity was performed and the date the activity is recorded on the document.

4. Document the explanation to substantiate the entry and the reason for the delay in recording.

5. Missing entry in the GMP records for non-retrieval data should be handled through event investigation procedure (For example, operator missed the reading of drying temperature during the operation, where there is no automatic data recording mechanism in place).

WORKING WITH BLANK OR UNUSED SPACE

Blank/Unused space in the GMP records should be strikeout as below with single line with sign and date to ensure that record cannot be added to a later date.

CANCELLATION OF GMP RECORDS

Cancellation of GMP records should only be allowed in the rare case with the approval of QA and in exceptional cases such as spillage of chemical on the record. Event investigation procedure should be followed to determine further course of action. The reason for cancellation should be documented for cancellation of the document and signed by area person in-charge and QA.