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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 applie...

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   comminu...