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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SOP ON JOB RESPONSIBILITY Job responsibilities are what an organization uses to define the work that needs to be performed in a role and the functions that an employee are accountable for.
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…
