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Qualification Stages For Equipment, Facilities, Utilities And System.

Qualification  Steps For Equipment, Facilities, Utilities And System. Qualification activities should consider all stages from initial development of the user requirements specification through to the end of use of the equipment, facility, utility or system. The main stages and some suggested criteria (although this depends on individual project circumstances and may be different) which could […]

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SOP For Risk Management

SOP For Risk Management. Objective :- The purpose of this SOP is to lay out the procedure for Risk Management (risk identification, analysis, evaluation, reduction / mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity of the drug product by using FMEA (Failure Mode Effect Analysis). Scope:-  The

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Quality Risk Management In Pharmaceutical Industry.

Quality Risk Management In Pharmaceutical Industry. Quality risk management: A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. Principles of Quality Risk Management Two primary principles of quality risk management are: The evaluation of the risk to quality should be

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Prevention of Cross Contamination in Pharmaceutical Industry

Prevention of Cross Contamination in Pharmaceutical Industry. Normally, the production of non-medicinal products should be avoided in areas and with equipment destined for the production of medicinal products but, where justified, could be allowed where the measures to prevent cross-contamination with medicinal products described in Eudralex Volume 4 (Chapter 3 & 5) can be applied.

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SPECIFICATIONS FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS ( QUALITY CONTROL)

SPECIFICATIONS: Test Procedures And Acceptance Criteria For New Drug Substances And New Drug Products: Chemical Substance. Specifications: Definition and Justification Definition of Specifications:- A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the

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SOP For Pest & Rodent Control

SOP For Pest & Rodent Control Objective :- To lay out the procedure of the Pest & Rodent control in the manufacturing Plant. Scope :- The SOP is applicable for Pest & Rodent control in the manufacturing Plant. Responsibility :- Housekeeping department officer/Executives  shall be Responsible for effective application OF SOP For Pest  & Rodent

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SOP For Documentation Control Procedure

SOP For Documentation Control Procedure Standard Operating Procedures for Approval  & Control documentation( SOP For Documentation & Data Control)  in Pharmaceutical Industry.  Objective :- The purpose of this SOP to lay out the procedure for the preparation, Review, Approval, Distribution, Revision , Retrieval, Archival & Destruction of the Master/Control Documents existing in manufacturing Unit &

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Evaluation of RETESTING In Pharmaceutical (Quality Control) Industry.

Evaluation of RETESTING In Pharmaceutical (Quality Control) Industry. Evaluate the company’s retesting SOP for compliance with scientifically sound and appropriate procedures. A very important ruling in one recent court decision sets forth a procedure to govern the retesting program. This district court ruling provides an excellent guide to use in evaluating some aspects of a pharmaceutical laboratory,

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FAILURE (OUT-OF-SPECIFICATION) OOS LABORATORY RESULTS (USFDA)

FAILURE (OUT-OF-SPECIFICATION) OOS LABORATORY RESULTS (USFDA) Evaluate the company’s system to investigate laboratory test failures (OOS). These investigations represent a key issue in deciding whether a product may be released or rejected and form the basis for retesting, and resampling. In a recent court decision the judge used the term “out-of-specification” (OOS) laboratory result rather

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