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Audit and Guideline

Checklist in Quality control for Audit Preparation of FDA & USFDA

Checklist in Quality control for Audit Preparation of FDA & USFDA Personnel Organogram of Quality control departments List of Employee and education details Individual Job Description Training Record of Individual employee as per   individual Job Responsibility  and Training Log and training assessments records Analyst Qualification records as per  individual Job Responsibility and  …

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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 Guidances: FDA and Global

Process Validation Guidances: 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 …

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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 for active substances without introduction of …

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Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification

Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification 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 …

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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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