Year: 2018

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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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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Pharmaceutical Quality System Elements & Change Management System (ICHQ10)

Pharmaceutical Quality System Elements & Change Management System As per ICH Q10 The elements described below might be, required in part under regional GMP regulations. However, the Q10 model’s intent is to enhance these elements in order to promote the lifecycle approach to product quality. These four elements are: • Process performance and product quality monitoring …

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