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SOP on ENTRY, EXIT & GOWNING PROCEDURE IN MICROBIOLOGY TESTING AREA( Non- Sterile ).

SOP on ENTRY, EXIT & GOWNING PROCEDURE IN MICROBIOLOGY TESTING AREA( Non- Sterile ). OBJECTIVE :- The objective of this SOP is to give exact idea about the procedure for entry exit & gowning in Microbiology testing area. SCOPE:- This SOP is applicable for the entry exit & gowning in microbiology testing area. RESPONSIBILITY:- Microbiologist, Lab Assistant […]

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What are the responsibilities of a quality control?

What are the responsibilities of a Quality Control?( As per EudraLex Vol-4 & USFDA) Control laboratory premises and equipment should meet the general and specific requirements for Quality Control areas given in Chapter 3. Laboratory equipment should not be routinely moved between high risk areas to avoid accidental cross-contamination. In particular, the microbiological laboratory should

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What are the Job Responsibilities of Quality Control Head & Quality Unit Joint Responsibilities.

Job responsibilities of The head of Quality Control & Joint Responsibility of The heads of Production, Quality Control,Head of Quality Assurance or Head of Quality Unit To approve or reject, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products; To ensure that all necessary testing is carried out and the associated records

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The Role of the Qualified Person in European Pharmaceutical Regulations.

The Role of the Qualified Person in European Pharmaceutical Regulations.(EudraLex Vol:4) The role of the Qualified Person In European Pharmaceutical Regulations As per EudraLex Volume 4; Chapter 2 :- Personnel. The duties of the Qualified Person(s) are described in Article 51 of Directive 2001/83/EC, and can be summarised as follows: a) for medicinal products manufactured within

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Good Documentation Practices of BMR & BPR, Processing & Packaging Instructions,Sampling ,Testing Procedures and Records.

Good Documentation Practices of BMR & BPR, Processing & Packaging Instructions,Sampling ,Testing Procedures and records. (EudraLex  Volume-4) Manufacturing Formula and Processing Instructions Approved, written Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured. The Manufacturing Formula should include: a) The name of the product, with a product reference

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Good Documentation Practice of Specification, Packaging Materials & Retention of Documents.

Generation and Control of Specifications for Intermediate, Bulk &  Finished Products  and Packaging Materials &  Retention of Documents.(EudraLex 4) All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in

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Good Documentation Practice in Pharmaceutical Industry (EudraLex Vol- 4)

Good Documentation Practice in Pharmaceutical Industry ( As Per EudraLex Vol- 4) Principle Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be fully defined in the manufacturer’s Quality Management System. Documentation may exist

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MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10)

MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system. Resource Management (a) Management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain

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Pharmaceutical Quality System (ICH Q10)

Pharmaceutical Quality System Guideline as per ICH Q10.    Introduction This document establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. Throughout this guideline, the term “pharmaceutical quality system” refers to the ICH Q10 model. ICH Q10 describes

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SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites.

  SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites. PROCEDURE: Carryout the microbiological testing of the drain as per procedure mentioned below. Prepare the swab sticks. After sterilization mark the swab sticks with location I.D. and date of sampling. Take the swabs at the respective area and withdraw the sample from critical

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