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Part 1 – GMP Standard Operating Procedures
1.1 – Validation Procedures SOPs
1.1.1 – Process/Cleaning/Method Validation Procedures
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This procedure describes general validation concepts and practices, the way processes and systems must be qualified/validated and the confirmatory documentation required. Here you will find the philosophy of validation, responsibilities, validation approaches of design qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, computer validation, general and specific criteria of validation, validation documentation and change control, validation reporting, guidelines of validation acceptance criteria.
This procedure contains step by step instruction on initiation of revalidation categories, changes that warrant revalidation programs, basic steps of revalidation procedure, revalidation activities and specific responsibilities, revalidation protocols, revalidation timing, equipment checklist, revalidation discrepancy procedure, release of revalidated equipment, preparation of the revalidation reporting file.
This procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an analytical testing procedure. The procedures set out in this SOP apply to qualitative and quantitative analytical methods which are used to test finished goods, in-process material, excipients and raw materials in support of registration documentation and cleaning validations and management responsibilities towards completing those method validation tasks.
This SOP describes the types of cleaning process and cleaning agents of process equipments and their validation, complete instruction on cleaning validation procedure, calculation of acceptance limits for rinse and swab samples, calculation of acceptance limits for swabs, analytical method validation for cleaning, cleaning validation test protocols and change control for revalidation.
This procedure describes the validation practices for laboratory instrument/equipment to be validated or calibrated and the confirmatory documentation required showing that the instrument/equipment is capable and operating effectively for its intended purpose. This procedure has practical instruction on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to be performed by the qualified equipment service technician in the presence of the laboratory staff with reference to the instrument/equipment manual.
This procedure describes in detail the procedures for the procurement of equipment, incorporating standardized demand specifications and Installation Qualification documentation, to ensure that equipment procured complies with in-house requirements and standards and conform to Good Engineering Practice, to detail the general procedure to be followed regarding the reporting of Factory and Site Acceptance Tests, to detail the manner by which the equipment Installation Qualification is documented.
The purpose of this SOP is to define common procedures to follow when organizing Trials/Evaluation Studies for the purpose of process improvement, equipment capability and validation studies. It defines the responsibilities within the trial process and documents that need to be considered when preparing the Trial documentation to ensure that the trial meets GMP and where applicable validation requirements. This SOP defines the procedures for conducting in house stand-alone trials on systems, processes and equipment. There can be an overlap between a trial and validation in that Trial documentation may form part of a latter process validation, (i.e. concurrent and prospective validation) and qualifications (OQ, PQ).
This SOP defines the procedure for cleaning, passivating and derouging the purified water system at a GMP site. The procedure may be performed after construction, following invasive repair or following maintenance. The various parts of this procedure are to be performed as necessary. Parts of this procedure may not always be executed at the same time (e.g., The storage tank for the purified water may be cleaned and passivated without cleaning and passivating the ringmain).
The scope of this procedure includes the validation of 1. Sampling methods used to determine residues after cleaning of manufacturing and packaging equipment used for the production of commercial product. 2. Analytical methods to detect residue after cleaning of manufacturing and packaging equipment used for the production of commercial product.
The objective of this Standard Operating Procedure is to describe the actions required to handle deviations encountered during validation studies.
The Validation Master Plan is designed to provide a planned and systematic framework within which all validation activities will occur. This document will also ensure that the manufacturing facilities comply with the local applicable GMP regulations and site requirements for validation.
This policy applies to all production process used for manufacture of commercial drug products or in-process materials for commercial drug products. Excluded form this scope is filling of tablets and capsules and labelling and secondary packaging of all drug products.
This validation guideline describes the approach and methods which will be used for the qualification of equipment at a GMP manufacturing site. The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing requirements for the validation of the equipment that is involved, directly or indirectly, in the manufacturing and testing processes. The plan pertains to the qualification of processes and laboratory equipment.
The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing required for the validation of the facilities and utilities that are involved, directly or indirectly, in the manufacturing processes at a GMP site.
This procedure is applicable to validation sampling and testing for all new product introductions, and when changes to manufacturing procedures, manufacturing equipment, or raw materials warrant process validation. Each situation will be assessed on an individual basis, and the appropriate sections of this document shall be applied.
The purpose of this Standard Operating Procedure is to describe the evaluation process for a new, or a change of, source raw material used to manufacture Drug Products at the GMP manufacturing facility. The procedure will provide a documented means of assuring that the changes are identified, documented, authorised and implemented taking due account of quality, regulatory and validation factors as well as environmental and safety issues.
To outline the requirements for preparation, review, approval and execution of process validation protocols and preparation, review and approval of process validation reports for semi solid and solid dose products manufactured at a GMP Manufacturing Site.
The purpose of cleaning validation is to provide documented evidence that the cleaning process is effective in removing residues of a product, cleaning agent or microbial contamination to below a predetermined level. The objective of this guideline is to describe the approach and methods, which will be used to validate cleaning and sanitation procedures involved in GMP processes employed in GMP Site Manufacturing facilities.
The purpose of the VPP is to, 1. Establish a plan for the overall validation effort and validation lifecycle to describe the extent of the validation effort required to meet Site and regulatory requirements. 2. Define Validation Deliverables for the computer system. 3. Provide a standardized format for Validation Project Plans.
This procedure serves as a guideline for the development of a User Requirement Specification (URS) document and Functional Requirement Specification (FRS) document for a computer system at a GMP manufacturing facility.
This SOP is to provide guidelines to ensure that materials that are brought into the manufacturing plant for trial purposes and not recorded into Material database are still accompanied by documentation so that their usage is recorded and reconciled and equipment that they contact is also recorded.
This SOP covers the validated Direct Impact Systems (including the facilities, utilities, equipment, process control systems, computer / automation systems) and Processes in production, storage and distribution of drug products in a GMP site.
The purpose of this SOP is to define common procedures to be followed when organising Trials, including allocation of responsibility to coordinate the Trial and suggestion of what needs to be considered when preparing the Trial documentation.