QA & QC

Investigating Out-of-Specification

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Investigating Out-of-Specification IDENTIFYING AND ASSESSING OOS TEST RESULTS — PHASE I: LABORATORY INVESTIGATION PHASE II:  FULL-SCALE OOS INVESTIGATION    

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PROCEDURE FOR CALIBRATION OF REFRIGERATOR

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OBJECTIVE:To describe the calibration procedure for distribution of temperature within the chamber of Refrigerator. SCOPE: his SOP shall be applicable for Calibration of Refrigerator at Pharmaceutical Industries. RESPONSIBILITY :             Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control PROCEDURE : Operate the refrigerator as per Standard …

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STABILITY STUDY MANAGEMENT

STABILITY STUDY MANAGEMENT Stability Study Management – To lay down the procedure to conduct stability studies of the drug product (dosage forms)/ Drug substances (API). This Procedure describes the procedure for assigning the stability of drug substances (Active pharma ingredients) and drug products (Packed finished dosage forms). The purpose of …

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In-process control of oral drug product during manufacturing & Packing

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Objective To lay down the procedure for in-process control of oral drug products during manufacturing & Packing. Scope This procedure is applicable for in-process sampling, analysis, and reporting to be carried out during manufacturing and packing of drug products at the formulation Plant. Responsibility Quality Assurance and production personnel shall …

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SAMPLING OF PACKING MATERIALS

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OBJECTIVE To lay down a procedure for sampling of packaging materials. SCOPE To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Quality Assurance Manager PROCEDURE …

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PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER

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1.0       OBJECTIVE To lay down the procedure for operation and cleaning of unit dose sampler. 2.0     SCOPE This SOP shall be applicable for IPQA area in Quality Assurance.             3.0       RESPONSIBILITY In process Quality Assurance Executive /Officer 4.0       ACCOUNTABILITY Head Quality Assurance 5.0       PROCEDURE FOR OPERATING 5.1       Check the Status …

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SOP on QUALITY RISK MANAGEMENT (RISK ASSESSMENT)

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1.0 Objective: To provide a procedure for carrying out Risk assessment, evaluation, mitigation and review of risk by employing appropriate tool of Quality Risk Management Process. 2.0 Scope: Applicable to different aspects of pharmaceutical quality like development, manufacturing, testing, distribution, inspection and submission/review processes throughout the life cycle of drug …

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STABILITY STUDY PROTOCOL

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STABILITY STUDY PROTOCOL THIS PROTOCOL IS: Lisinopril and Hydrochlorothiazide tablets 10+12.5 mg CONTENTS: Each uncoated tablet contains: Lisinopril dihydrate equivalent to Lisinopril 10mg Hydrochlorothiazide                                           12.5mg SHELF LIFE: 24 months DOSAGE FORM: Tablet MANUFACTURED AT: TYPE OF STABILITY STUDIES: Accelerated stability studies 40 + 20C / 75 + 5 …

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SOP on the Transfer of Technology for Analytical Method

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Objective: To lay down the procedure for Transfer of Technology for Analytical Methods. Scope: This procedure is applicable for Transfer of technology for Analytical Methods from ARD to Formulation Unit. Responsibility: Responsibility of Sending Unit (ARD ) are : Preparation of Technology transfer Protocol for Analytical Method transfer. Execution of …

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Why disinfectant sterilization required in pharma injectable?

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Disinfection Disinfection is a process that is designed to kill actively growing and vegetative microbial microorganisms to a certain level, and it does not, unless the disinfectant is classified as a sterilant, apply to bacterial endospores. Disinfection a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on …

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