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Validation Master Plan for Pharmaceutical Industry

Author of the document Prepared by         Designation: Signature Date: Reviewer of the document for correctness Reviewed by:         Designation: Signature: Date: Approver of the document for use Approved by: Designation: Signature: Date:         Table of contents: 1. Validation policy 2. Scope 3. Responsibility 3.1 Production department 3.2 Quality control department 3.3 Engineering department 3.4 Quality assurance department 4. Site...

SOP for Quality Management System (Documentation) in Pharmaceutical Industry

 Objective: To lay down a procedure for origination and review of the Site Master File, Quality     Manual, Quality Policy, SOPs, forms and logs. Scope: This procedure is applicable for following documents: - Quality Manual/Policy -  Site...

SOP for Incident Handling in Pharmaceutical Industry: PharmaState

1. Objective: To lay down a procedure for handling of incidents. Scope: This procedure is applicable for accidental and untoward events occurring in factory premises. Incidents may occur even though standard procedures are not violated. ...

Procedure for Cleaning and Monitoring of Clean Room Pass Boxes

  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...

Working Principles for Dynamic and Static Pass Boxes

(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...

Validation of Clean Room Pass Boxes

(A) Clean Room: A Clean Room is an area in which the quantity and size of air- borne particles are controlled in order to limit contamination. A Clean Room is constructed and operated in a...

Pharmaceutical Quality/Manufacturing Standards (CGMP)- US FDA

Below is a sortable listing of Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidances                          CATEGORY                             TITLE Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) Pharmaceutical Quality/Manufacturing Standards (CGMP) Current...

Pharma Regulations and Guidelines-India, Easy Access Links

(1). Regulations & Guidelines:              CDSCO    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.             NPPA   Drugs...

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