Validation & Qualification

Process Validation: General Principles (USFDA) in Pharma Industry This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes. FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle. The lifecycle concept links …

Establishment of a Control Procedure in Pharma for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals A formal change control system should be established to evaluate all changes that may affect production and control of the intermediate or API. There should be a …

Qualification of existing facilities, systems, equipment, and utilities An existing facility has a mixture of new fully qualified equipment (DQ, IQ, OQ, PQ) and partially qualified/ unqualified equipment. Through many years of use, it can usually be shown that facilities, systems, equipment, and utilities can function to varied requirements. Nevertheless, …

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Qualification & Validation of Equipment Equipment qualification as required by the FDA requires verification documentation to start with the Validation Master Plan (VMP) and flow through a series of documents that define the scope and tasks required to successfully execute your equipment qualification task. The VMP dictates the actions that all persons involved …

PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM OBJECTIVE To describe the Performance Qualification procedure to be used during validation of purified water system in order to: a) ensure the system reproducibility over an appropriate time period as per user requirement specifications. b) ensure that the system is showing consistency in producing …

Guidance Document Cleaning Validation Scope Introduction Principles Validation of Cleaning Processes Equipment and Personnel Microbiological Considerations Documentation Analytical Methods Sampling, Rinsing, Rinse Samples and Detergents Establishment of Limits Change Control/revalidation References 3.1 The objective of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of …

Non-sterile process validation Process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process at each site of manufacture. The validation should be carried out in accordance with good manufacturing practices (GMP) and data should be held at the manufacturing location and made available …

Performance Qualification Protocol of Dispensing Booth      

Factory Acceptance Test for Automatic Strip Packing Machine machine name AUTOMATIC STRIP PACKING MACHINE Client Name & Address M/S. document name factory acceptance test PROTOCOL no. SCT/FAT/000 Revision no. 00 MACHINE SR. NO. Table of Contents Sr. No. Title Page No. 1.0         Purpose 2.0         Scope 3.0         Responsibilities 4.0         System description …