Quality Assurance

SOP For Handling of Power Failure in Plant

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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Handling of Pharmaceutical Market Complaint

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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SOP For Job Responsibility

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

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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Complaints And Recalls Handling In API Manufacturing Unit- Pharma

COMPLAINTS AND RECALLS All quality related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure. Complaint records should include: − Name and address of complainant; − Name (and, where appropriate, title) and phone number of person submitting the complaint; − Complaint nature (including name and batch number …

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