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 […]
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. (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
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
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) 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
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. 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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Most Important Definitions In Clinical Trials. As Per ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE – E6(R1) What is Clinical Trials? What are all terms used in Clinical Trials? How ICH Guideline Define all these terms? ICH has mentioned all clinical study related terms in ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1) Clinical
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Before attending any QA&QC interviews be prepared for the below question – Answer QA&QC DEPARTMENT List of all questions asked in interviews of quality control and quality assurance 1 Can any deviation be changed into the change control? 2 What is the difference between Humidity and Relative Humidity? 3 What should be the temperature
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