Objective :To lay down procedure for cleaning and operation of static pass box. SCOPE The standard operating procedure is applicable to the static pass box present in manufacturing plant . Equipment no. Make klenziad Capacity 915X610X915mm Location Under test area 3.0 RESPONSIBILTY Production executive/supervisor shall be responsible for implementing the sop for cleaning and operation…
Calibration procedure for gas chromatograph clarus 500 with headspace (Perkin Elmer) OBJECTIVE To lay down the procedure for calibration of GC Clarus 500 with headspace (Perkin Elmer ) SCOPE This SOP shall be applicable for the GC Clarus 500 with headspace (Perkin Elmer). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. CALIBRATION PARAMETERS Oven temperature…
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Area clearance during batch/product change over in Pilot Production facility. Quality Assurance OBJECTIVE : To provide procedure for Area clearance during batch/product change over in Pilot Production facility. RESPONSIBILITY : Officer Quality Assurance for implementation Quality Assurance Manager to ensure compliance. PROCEDURE : Note: (i) Type-A Area clearance : During batch change over of same…
Preparation, Approval and Control of Guidelines (Quality Assurance) OBJECTIVE : To lay down the procedure for the preparation, approval and control of Guidelines. RESPONSIBILITY : All the personnel shall to be familiar with this SOP. The approver to ensure that all proposed Guidelines conform to this SOP before approving any Guidelines. PROCEDURE : Definition of…
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Blister Packing Machine (Alu-Alu ) Automatic Blister Packing Machine design of the machine is ergonomic and used for both the Cold Forming (ALU/ALU) and Thermo Forming (PVC/ALU) blister packs. This machine is suitable for Large production batches in the pharmaceutical industry. The main movements are mechanical and pneumatic, and all the control systems used in the equipment…
Technology transfer OBJECTIVE : To lay down a procedure for technology transfer of New products . SCOPE : The scope of this SOP is to all the new Products for which Technology has been provided by outside party or from R&D. RESPONSIBILITY : Head of Production, QA Head, QC Head shall be responsible to follow…
Correction of Documentation Errors Objective To lay down a procedure for correcting the errors in documentation. Scope This Standard Operating Procedure is applicable for correction of all documentation error in written procedures (SOPs, Specifications, STPs, or TDs etc.) and records (Batch Manufacturing Records, Raw Data, Log Books, etc.) Responsibility Each employee shall be responsible to…
New Product Design and Development Process Objective To lay down a Procedure for New Product Design and Development Process. Scope This Standard Operating Procedure is applicable all pharmaceutical formulation plants. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of data for DCGI permission. Head, RA…
Approval of vendors (Packing Materials) OBJECTIVE: To lay down a procedure for approval of new vendors for packaging materials. SCOPE: This SOP is applicable to all new manufacturer / suppliers of packaging materials RESPONSIBILITY: Purchase, QC and QA personnel shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY : QA Head shall…
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 the vendor as per GMP…
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CLEANING VALIDATION FOR DRUG PRODUCTS To establish and explain the procedure to be followed for the Validation of Standard Cleaning Procedures (SOP’s), in order to demonstrate that cleaning procedures are effective, adequate and shall consistently remove the residues (chemical, microbial and cleaning agent, if any) from the equipment to a pre-determined level of acceptance. SCOPE…
Process Validation Guidance: FDA and Global Process Validation Lifecycle Approach Overview – History and development, FDA commentary, Is the lifecycle approach new? Lifecycle Approach Stages Process Understanding (Process Design) Process Demonstration (Process Qualification) Maintaining Validation (Continued Process Verification) Fundamental Concepts The “process of process validation” Enhanced execution Comparison to the traditional approach Regulatory Guidance :…
New EU Requirements for Qualification & Validation An 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 It may be used as supplementary optional guidance for active substances without…
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Concept of URS,DQ,IQ,OQ,PQ in Pharma According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” It is a requirement for Good Manufacturing Practices and other…
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 substances in conventional dosage forms…
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The role of dissolution in drug development Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal analytical test used for detecting…
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 drug products manufactured / packaged…
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 a facility consistently controls potential…
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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 a clinical trial, including products…
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 of any new drug. •…
