PHARMA KING ACE

 In pharmaceutical manufacturing, particularly in the **Rapid Mixer Granulator (RMG)**, several **Critical Process Parameters (CPPs)** must be closely controlled to ensure the granulation process is consistent, reproducible, and results in a high-quality product. These parameters directly influence the granule properties such as size, density, and uniformity, which in turn affect the drug's dissolution, bioavailability, and stability. ### Key Critical Process Parameters (CPPs) in RMG: 1. **Impeller Speed (Mixing Speed)**:    - **Impact**: The impeller speed determines the shear and intensity of the mixing action. Too low a speed may lead to inadequate mixing, while too high can result in excessive shearing and over-granulation, which can cause poor flowability and excessive fines.    - **Control**: Typically adjusted based on the formulation requirements, with optimal speeds being set for different stages of granulation. 2. **Chopper Speed**:    - **Im...

 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 applie...

  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 integr...

  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 

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   comminu...

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...