Audit and Guideline

Drug stability in Pharmaceutical products Pharmaceutical products are assigned a shelf life which determines the time when a product is considered to be safe and effective under storage condition. Stability studies should be based on the basis of pharmaceutical R&D and regulatory requirements. Degradation studies reveal the intrinsic chemical properties …

General Terminology used for good Hand hygiene practices as per USFDA Hand hygiene practices Antiseptic handwashing Washing hands with soap and water,or other detergents containing an antiseptic agent. Antiseptic handrubbing (or handrubbing). Applying an antiseptic handrub to reduce or inhibit the growth of microorganisms without the need for an exogenous source of water …

Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist Building and Facilities. Check whether Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance. Floors, walls and ceilings are constructed of …

COMPRESSED MEDICAL GASES AS PER USFDA GUIDELINE INTRODUCTION This guideline describes practices and procedures for compressed medical gas (CMG) fillers (including companies engaged in home respiratory services) that constitute acceptable means of complying with certain sections of the current good manufacturing practice (CGMP) regulations for drug products (21 CFR Parts …

Data Integrity In Pharmaceuticals Data integrity: Data integrity is a fundamental component of information security. In its broadest use, “data integrity” refers to the accuracy, reliability and consistency of data stored over its entire life-cycle in a database, data warehouse, data mart or other construct. The term – Data Integrity …

PROCEDURE FOR VIABLE AIR MONITORING OBJECTIVE:To lay down a procedure for environmental monitoring of air. SCOPE:This SOP shall provide the procedure for monitoring the viable air borne count. RESPONSIBILITY :Quality Control Executive / Officer. ACCOUNTABILITY:Head Quality Assurance. PROCEDURE:The microbial environmental conditions of unit II shall be monitored by Settle plate …

PHARMACOVIGILANCE PLAN AS PER ICH Pharmacovigilance plan especially in preparation for the early postmarketing period of a new drug .  Pharmacovigilance Plan that might be submitted at the time of licence application. Pharmacovigilance plan can be used by sponsors to develop a stand-alone document for regions that prefer this approach …

INPROCESS CONTROL DURING TABLET MANUFACTURING OBJECTIVE:        To lay down the procedure for In process Controls during Tablet Manufacturing. SCOPE:                 This SOP shall be applicable for in process controls during tablets manufacturing. RESPONSIBILITY:             In process Quality Assurance Executive/Officer. ACCOUNTABILITY:          Head Quality Assurance. PROCEDURE: Carry out line clearance at each …

RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST Material Name: AR No./MRR No./ Date: SNo. Description Check Point 1 Environmental Conditions Temperature RH 2 Under test label Affixed / Not affixed 3 Packing Packed in carboys / drums Packed in fiber/plastic drums with polybag inside Packed in PP woven …

International Organization for Standardization ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies.Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. The ISO is a multinational agency . It …