Quality Assurance
Cleaning Validation in Pharmaceutical Industry : Essential Tips and Best Practice
By following these tips and best practices, companies in the pharmaceutical industry can ensure that their cleaning processes are effective and compliant with GMP requirements. By maintaining a clean and well-controlled environment, companies can help prevent contamination and ensure the quality and safety of their products.
SOP For Handling of Reprocessing, Reworking and Recovery
OBJECTIVE: The purpose of this SOP is to lay down a procedure for reprocessing, reworking and recovery of the drug products. SCOPE: This SOP is applicable for handling of reprocessing, reworking and recovery of the drug products, at different stages of manufacturing, at the manufacturing facility. RESPONSIBILITY: Authorized Designee of Quality Assurance shall …
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SOP For Calibration
OBJECTIVE To define the general requirements for an effective calibration control system to ensure that applicable measuring and test equipment is calibrated and maintained within accuracy limits sufficient for their intended purpose. SCOPE This procedure is applicable for calibration of all equipment /instrument/ measuring devices. RESPONSIBILITY Follow up: Concern Department Officer/Executive Overall responsibility: Concern …
SOP for Handling of Artwork
OBJECTIVE: The objective of this SOP is to lay down a procedure for preparation, approval, distribution, revision, retrieval and destruction of artwork. SCOPE: This SOP is applicable for preparation, approval, distribution, revision, retrieval and destruction of artwork at the manufacturing facility. RESPONSIBILITY: Marketing: Responsible for Color and Design Production Department: Responsible for mentioning size as …
SOP For Failure Investigation
OBJECTIVE : The purpose of this SOP is to lay down the procedure for ( Failure Investigation ) investigation failure of any activity to meet its predetermined specification, limits or acceptance criteria SCOPE : This SOP is applicable to process failures as well as non process failures (e.g. operator related). This SOP is not applicable …
SOP For Men and Material Movement
OBJECTIVE: The purpose of this SOP is to lay down the procedure for men and material movement. SCOPE: This SOP is applicable for material movement across the different blocks and area and men movement in miscellaneous areas at the manufacturing facility. RESPONSIBILITY: Each individual entering into the area shall be responsible to follow the practice. …
SOP For Acceptance Quality Level
1.0 OBJECTIVE To lay down the procedure for the visual inspection and statistical evaluation of a batch ( Acceptance Quality Level). SCOPE This procedure is applicable for the visual inspection and statistical evaluation of a batch during different manufacturing stages i.e. compression, encapsulation, coating and packing in the company (XXX Name of the company). …
SOP For New Product Introduction
OBJECTIVE : The purpose of this SOP is to lay down the procedure for introduction of new product at the manufacturing location. SCOPE : This SOP is applicable for all new products including exhibit and validation batches being taken for manufacturing facility. Responsibility: Quality Control: Prepare and send the Specifications, Standard Test Procedures and Method …