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

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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.

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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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Most Common Interview Questions For Quality Assurance & Quality Control Department.

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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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Most Common Interview Questions For Regulatory Affairs Department.

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Most Common Interview Questions For Regulatory Affairs Department.   1.What is Regulatory Affairs? Ans-Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their …

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II)

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II) Out Of Specification( OOS ) :-  The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification( OOS ). We have seen in last …

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How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :-  The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification(OOS).   What USFDA guideline says about Investigation of Out …

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What is Data Integrity In Pharmaceutical Industry…???

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What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working, …

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What is Minimum Requirements of EU Agencies from Production section of Manufacturing site.?

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Minimum Requirements in  Production section  for EU authorized Human Pharmaceutical products manufacturing site as per Eudralex Volume 4  part 1 Chapter 5: Production.    Principle Production operations must follow clearly defined procedures; they must comply with the principles of Good Manufacturing Practice in order to obtain products of the requisite quality and be in accordance with the relevant …

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Minimum Requirements of Premises and Equipment as per EU Guideline before going for EU Regulatory Audit.

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Minimum Requirements of EU for Premises and Equipment in Human Pharmaceutical products Manufacturing site  as per EU Guideline before going for EU Regulatory Audit.   PRINCIPLE Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk …

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