USFDA New Data Integrity and Compliance Guideline
(published in Dec 2018) Background : The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (cGMP)…
SOP -List of Stamps
Objective : To lay down procedure for usage of stamps for issuance of documents by QA. Scope : This procedure is applicable to all documents,…
SOP on Market Complaint
To lay down the procedure for handling of Market Complaints related to Intermediates &/or API.
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…
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