Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing plant. A detailed checklist for review of BMR and BPR for Draft Copy as well as Filled Copy of Batch Manufacturing/Packing Records. Procedure for BMR & BPR Review 1.0 PURPOSE: The purpose of […]
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Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Control, Microbiology, Utility, Stores, etc at the pharmaceutical drug manufacturing plant. Procedure for Handling of Power Failure in Pharma 1.0 Purpose: To lay down a procedure for handling power failure situations. 2.0 Scope:This procedure is applicable to handling power failure
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Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses. Procedure for Finished Product Batch Release1.0 PURPOSE: To lay down the procedure for approval and release of the finished product batch. 2.0 SCOPE: This Standard Operating Procedure is applicable for all
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At EU-level there are not fixed rules about how risk assessments should be undertaken (you should check the specific legislation relating to risk assessment in your country). However, there are two principles which should always be borne in mind when approaching a risk assessment: to structure the assessment to ensure that all relevant hazards and
European Guidance On:
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CAPA (Corrective Action & Preventive Action) is an area that we talk about often, mainly because it’s still such a big issue for companies. This time, we’re looking at a step-by-step process that, if done well, should help any company to get a good result from their CAPA process. A STEP-BY-STEP CAPA PROCESSThe key thing
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The laboratory or Quality organization management should establish, implement and maintain a quality management system appropriate to the scope of its activities, including the type, range and volume of testing and/or calibration, validation and verification activities it undertakes. The laboratory management should ensure that its policies, systems, programmes, procedures and instructions are described to the
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Principle. All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken. A person responsible for handling the complaints and deciding the measures to be taken should be designated, together with sufficient supporting staff to assist him or her. If this person
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The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Objective : The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Scope : This SOP is applicable to all responsible persons of pharmaceutical Industry
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Validation Master Plan A manufacturer should have a VMP which reflects the key elements of validation. It should be concise and clear and contain at least the following: ‒title page and authorization (approval signatures and dates); ‒table of contents; ‒abbreviations and glossary; ‒validation policy; ‒philosophy, intention and approach to validation; ‒roles and responsibilities of relevant
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