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Table of contents:
1. Validation policy
3.1 Production department
3.2 Quality control department
3.3 Engineering department
3.4 Quality assurance department
To lay down a procedure for origination and review of the Site Master File, Quality Manual, Quality Policy, SOPs, forms and logs.
This procedure is applicable for following documents:
- Quality Manual/Policy
To lay down a procedure for handling of incidents.
This procedure is applicable for accidental and untoward events occurring in factory premises. Incidents may occur even though standard procedures are not violated.
Cleaning of Clean- Room Pass Boxes:
(A) Subject: Procedure for Cleaning of Class- Room Pass Boxes.
(B) Purpose: This procedure is applicable for Cleaning of Clean- Room Pass Boxes used in the formulation plant of pharmaceutical...
(1) Dynamic Pass Box: Procedure on the working of Dynamic Pass Box.
(A) Objective: This working principle is applicable for usage of Dynamic Pass Box in formulation plant of pharmaceutical company.
(B) Responsible Person: Production Officer/ Executive are the...
(1). Regulations & Guidelines:
Central Drugs Standard Control Organization (CDSCO), under MOHFW (Ministry of Health & Family Welfare), Government of India - provides information about Drug & Medical Devices regulatory requirements in India.