Audit and Guideline

LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER

LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER Dosage Form: Date / Time: Product: Batch No.  : Previous Product: Batch No.  : Vacuum cleaner ID No.: Stage areas / room & equipment Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time Vacuum cleaner Equipment ID No.: …

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Vendor Development and Approval (API and excipients)

Vendor Development and Approval (API and excipients) OBJECTIVE : To lay down a procedure for vendor audit for raw material, developing and approving the vendor who can consistently supply the raw materials with right quality and quantity at right time. SCOPE : This Standard Operating Procedure is applicable to approve …

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Process Validation Guidance: FDA and Global

Process Validation Guidance: FDA and Global OUTLINE Process Validation Lifecycle Approach Overview History and development Is the lifecycle approach really new? FDA commentary Lifecycle Approach Stages 1 — Process Understanding (Process Design) 2 — Process Demonstration (Process Qualification) 3 — Maintaining Validation (Continued Process Verification) Fundamental Concepts The “process of …

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New EU Requirements for Qualification & Validation

New EU Requirements for Qualification & Validation Updated version of Annex 15 ◦ Qualification and Validation Draft released in February 2014 Final version released on the 30th of March , 2015 Will be effective on 01 October 2015 4/3/2015 3 Improved Annex 15 May be used as supplementary optional guidance …

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Concept of URS,DQ,IQ,OQ,PQ in Pharma

Concept of URS,DQ,IQ,OQ,PQ in Pharma Introduction  Validation User Requirement Specification.(URS) Phase of validation Design qualification (DQ) Installation Qualification (IQ) Operation Qualification (OQ) Performance Qualification (PQ) Maintenance Qualification (MQ) Component Qualification (CQ) Instrument Re-Qualification According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence …

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Good storage practices for pharmaceuticals as per regulatory Guideline

Good storage practices for pharmaceuticals as per regulatory Guideline 1. Introduction 2. Glossary 3. Personnel 4. Premises and facilities 5. Storage requirements 6. Returned goods 7. Dispatch and transport 8. Product recall 1. Introduction The storage, transportation and distribution of pharmaceuticals. The stability testing of pharmaceutical products containing well-established drug …

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stability tests for pharmaceutical products

  Stability Definition These studies provide information about the packaging in that it is not reactive, additive, or absorptive so that the identity, strength, quality and purity of the drug product is not affected, also to provide clearance on stability process flow. To assessment of the stability characteristics of all …

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CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRY – AN OVERVIEW

CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRY – AN OVERVIEW Manufacturing of Pharmaceutical products shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important role. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within …

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An introduction to Clinical Trials

An Introduction to Clinical Trials What is Clinical Trials? A properly planned and executed clinical trial is a powerful experimental technique for assessing the effectiveness of an intervention What is an investigational product? ‘a pharmaceutical form of an active substance or placebo being tested or used as a reference in …

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Phases of clinical trials

Phases of clinical trials Contents • Introduction:Clinical research • Drug development phases • Pre-Phase 1 activities • Phases of Clinical trial • Regulatory approvals: IND & NDA • Summary of Clinical trial phases INTRODUCTION • Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy …

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Determining Whether to Submit an ANDA or a 505(b)(2) Application in USFDA Part II

Determining Whether to Submit an ANDA or a 505(b)(2) Application in USFDA Part II SUBMISSION THROUGH THE APPROPRIATE ABBREVIATED APPROVAL PATHWAY A. Regulatory Considerations for ANDAs and 505(b)(2) Applications 1. Duplicates FDA generally will refuse to file a 505(b)(2) application for a drug that is a duplicate of a listed …

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Determining Whether to Submit an ANDA or a 505(b)(2) Application in USFDA

Determining Whether to Submit an ANDA or a 505(b)(2) Application in USFDA This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of …

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Current Trends in Cleaning Validation

Current Trends in Cleaning Validation Rings on Buffer and Media Tanks Health based limits FDA Trends Process Understanding Trend 1: Rings in Buffer tanks Initial Incident Discovery   Background • Cleaning processes are designed based on – nature of the soil – condition of the soil – surface material – …

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Steps in Managing the Pharma Audit

Steps in Managing the Pharma Audit Introduction To achieve its’ objective efficiently and cost-effectively an audit should be thoroughly planned, carefully structured, systematically performed, faithfully reported, and remedial actions progressed to a timely and satisfactory conclusion. As with most issues involving people, clear and effective communication with the relevant stakeholders is essential if business …

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Technical Report Series (TRS) Biologicals

Technical Report Series (TRS) Biologicals Chronological listing 68th report: TRS 1011: 2017 67th report: TRS 1004: 2016 66th report: TRS 999: 2015 pdf, 1.31Mb 65th report: TRS 993: 2014 64th report: TRS 987: 2013 63rd report: TRS 980: 2012 pdf, 2.22Mb 62nd report: TRS 979: 2011 pdf, 3.23Mb 61st report: TRS …

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Computerised systems – EU GMP Annex 11

Computerised systems – EU GMP Annex 11 1. Appropriate controls for electronic documents such as templates should be implemented. Are there any specific requirements for templates of spreadsheets? H+V February 2011 Templates of spreadsheets help to avoid erroneous calculations from data remaining from previous calculations. They should be suitably checked for accuracy …

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Sampling of starting and packaging materials: Glycerol as per EU GMP

Sampling of starting and packaging materials: Glycerol as per EU GMP EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Glycerol 1. What is the background regarding international incidents of glycerol contamination? H+V December 2007 There is a history of sporadic reports from around the world of supplies …

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Question and Answers on WHO GMP

Question and Answers on WHO GMP Why is GMP important? Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers. Poor quality medicines can damage health A poor quality medicine may contain toxic substances that have been unintentionally added. A …

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Hygiene and cleanliness programs as per USFDA GMP in pharmaceuticals

Hygiene and cleanliness programs as per USFDA GMP in pharmaceuticals High standards of personal hygiene and cleanliness are essential. Hygiene programs should be established Eating, drinking, chewing or smoking, as well as the storage of food or personal medication should be prohibited in the production and storage area. Direct contact should be …

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Risk-based approach as per EU Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

Risk-based approach as per EU Good Manufacturing Practice specific to Advanced Therapy Medicinal Products Introduction ATMPs are complex products and risks may differ according to the type of product,nature/characteristics of the starting materials and level of complexity of the manufacturing process. It is also acknowledged that the finished product may entail …

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