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Important SOPs for Quality Assurance in Pharmaceutical Industry

Preparation, review, approval and control of SOPs Training procedure Handling and control of documents Change control Handling of deviations SOP for line clearance Handling of market complaint Preparation, approval and control of master...

SOP for finished product Inspection and Release in Pharmaceuticals

Objective: To lay down a procedure for finished product inspection and release. Scope: This procedure is applicable for all type of finished pharmaceutical product. Responsibility: Quality assurance, Warehouse and Production. Procedure: 4.1 Physical...

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...

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...

FROM ALCOA TO ALCOA PLUS- DATA INTEGRITY

  ALCOA:- Coined By: - Stan Woollen in Early 1990s.  1999 FDA Guidance:- ALCOA- To be acceptable; the data from the Clinical Trials should meet certain fundamental elements of quality whether collected or recorded electronically...

PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Scheme]- Guidelines & Links

                        All    Reference    Category  Section AIDE MEMOIRE ON ASSESSMENT OF QUALITY RISK MANAGEMENT (QRM) IMPLEMENTATION       PI 038-1 Documents for Inspectors Aide-Memoires AIDE MEMOIRE ON GMP PARTICULARITIES FOR CLINICAL TRIAL PRODUCTS        PI 021-2 Documents for Inspectors Aide-Memoires AIDE MEMOIRE ON INSPECTION OF BIOTECH      ...

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