Preparation, Approval, Review, and Control of Technical Directions for the Manufacture of Drug Products Objective To lay down a procedure for the Preparation, Approval, Review, and Control of Technical Directions for Manufacture of Drug Products. Scope This Standard Operating Procedure is applicable for the preparation and implementation of Technical Directions for all products manufactured at…
ROLE OF QUALITY ASSURANCE The quality assurance department shall be involved in all quality-related matters. The quality assurance department shall posses following responsibility but not limited to the same.
PROCEDURE FOR AGREEMENTS/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES AGREEMENTS Service Provider: A service provider is an organization or an individual who provides professional or expert advice/ service in a particular element of pharmaceutical Quality Service provider can be a Subject Matter Expert and/or a consultant. etc. Technical Team Technical team shall comprise of personnel from…
Guideline for Process Validation To define the procedure for exhibit batch monitoring and process validation of drug products for meeting all the predefined attributes and the process is capable of consistently delivering quality products. This involves the collection and evaluation of data from the process design stage through commercial production to establish scientific evidence that…
GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance In the complex and dynamic world of pharmaceuticals, ensuring the quality, safety, and compliance of products is of paramount importance. GxP, a set of regulations and guidelines that govern various aspects of pharmaceutical manufacturing, plays a critical role in maintaining industry standards. This blog explores the significance…
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Stability (ICH) Quiz 7 Q: What are the requirements regarding the number of primary batches for formal stability studies of a drug substance? A: Formal stability studies necessitate data from at least three primary batches of the drug substance. Q: What criteria must the primary batches meet for inclusion in formal stability studies? A: The…
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Stability (ICH Q1A) Quiz 1 Q: What is the purpose of the revised ICH Q1A guideline mentioned in the text? A: The purpose of the revised guideline, based on the ICH Q1A guideline, is to establish the stability data package necessary for the registration application of a new drug substance or drug product across the…
Quality Risk Management -Questions and answers Q1: What is the purpose of Quality Risk Management in the context of medicinal products? A1: Quality Risk Management serves as a systematic process for assessing, controlling, communicating, and reviewing risks related to the quality of medicinal products. It encompasses both proactive and retrospective approaches. Q2: What are the…
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Pharmaceutical Quality System Pharmaceutical Quality System – Questions and answers Q1: What is the main goal of a Pharmaceutical Quality System for medicinal product manufacturing? A1: The primary goal of a Pharmaceutical Quality System is to ensure the consistent delivery of medicinal products with appropriate quality attributes through the entire product lifecycle. Q2: How is…
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Good Manufacturing Practice for Medicinal Products Good Manufacturing Practice is that part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product specification. Good Manufacturing Practice is concerned with both production and…
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Product Quality Review Regular periodic or rolling quality reviews of all authorised medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements….
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SOP ON PREPARATION, HANDLING, AND REVISION OF VALIDATION MASTER PLAN The Validation Master Plan is different from a validation procedure (SOP), which describes the specific process for performing validation activities. When plans are written specifically for a single validation project, they are referred to as Validation Plans. Sometimes Validation Master Plans are written to cover…
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BATCH RELEASE SYSTEM AT VARIOUS MANUFACTURING STAGES Batch (Or Lot) A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into several sub-batches, which are later brought together to…
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