Category: Pharma Industry Guidelines
Formats for change control , deviation & categorization of changes.
Excerpt– 1) Do not retain this form and forward to the next after completion of review.2) Put N/A where not applicable.3) Attach an additional sheet…
Do’s & Dont’s in Microbiology Lab
Objective : To lay down the procedure of Do’s and Don’ts to be followed in Microbiology Laboratory. Scope: Applicable to Microbiology Lab. Responsibility: All persons…
CAPA Formats- CAPA Request Form & CAPA Register
Corrective Actions and Preventive Actions (CAPA). Download formats from links below- For any Feedback or suggestion, mail at: info@pharmastate.com
SOP on CAPA | Corrective Actions and Preventive Actions in Pharma Industry
Objective : To lay down the procedure of for identification, evaluation, implementation,effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA). 2.Scope: This…
SOP – Good Documentation Practices in Pharma Industry
1.Objective : To lay down a procedure for good documentation practices. 2. Scope: This procedure is applicable to all cGxP documents (electronic & manually generated)…
SOP of Signature Log | Pharmaceutical Industry
1. Purpose : To lay down the procedure for signature log. 2.Scope : This procedure is applicable to all employees working in a…
SOP ON SOP (HOW TO PREPARE SOP) – PHARMACEUTICAL INDUSTRY
1.Objective To lay down procedure for preparation, review, approval, issuance & retrieval of Standard Operating Procedure. (SOP) 2.Scope This procedure is applicable to preparation of…
SOP for User Requirement Specification in Pharmaceutical Industry
ObjectiveTo lay down a procedure for User requirement specification (URS). ScopeThis is applicable mainly to production equipment and utility systems. It shall also be applicable…
SOP for Document Numbering System
1. Objective To lay down a procedure for preparation of policy documents and numbering of qualification and validation documents. 2. Scope The SOP is applicable…
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