PHARMA KING ACE

Introduction The Indian pharmaceutical industry has long been regarded as the "pharmacy of the world," supplying affordable generic medicines to millions globally. However, in recent times, it faces a host of challenges that necessitate innovative solutions to maintain its competitive edge. In this blog, we will explore some of the current challenges faced by the Indian pharmaceutical industry and propose effective strategies to overcome them. Challenge 1: Changing Regulatory Landscape One of the primary challenges the Indian pharmaceutical industry faces is the evolving regulatory environment both domestically and internationally. Stringent regulations in various countries, including the US and Europe, have necessitated compliance with stricter quality standards and documentation requirements. Changing Regulatory Landscape Strategy: Implementing Quality Management Systems To overcome this challenge, pharmaceutical companies must invest in robust Quality Management Systems (Q...

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 ...

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...

  1.0 OBJECTIVE:        To lay down a procedure for return of Raw material & Packing materials from production department. 2.0 SCOPE:         This SOP shall be applicable for return of Raw & Packing materials from production department. 3.0 RESPONSIBILITY:         Stores Officer/Assistant 4.0 ACCOUNTABILITY:        HOD Stores 5.0 PROCEDURE: 5.1 Raw & Packing materials shall be returned  from Production Department to Stores Department only in the following cases: • Change in production plan. • Requirement of alternate AR No. / Replacement of issued material. • Balance Quantities after completion of Batch in case of Packing Material. 5.2 Production person shall fill “ Shop floor internal return note” with all   necessary detail...

DRUG MASTER FILE (DMF) Drug Master File (DMF) : is a document prepaired by a pharmaceutical manufacturer and submittedsolely at its discretion to the appropriate regulatory agency.DMF contains confidential and factual information about facilities, processes(includes drug product's chemistry, manufacture, stability, purity, impurity profile etc.) or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.DMF helps the manufacturer to keep relevant information secret and at the same time to sell the product to different customers using this drug within there final application.The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review ...