Validation Technology in the Pharmaceutical Industry - A Review

Authors

  • Mr. Anupam Gulabdhar Pandey

Keywords:

Validation, Validation Technology, Validation Master Plan

Abstract

Validation Master Plan is expected to serve as a guidance document for deciding the course of various actions and strategies for equipment acquisition, calibration of instruments, qualifications of equipment, system and other validation activities like personnel training and qualification, process, cleaning , analytical method validation, change control, risk analysis and key acceptance criteria, documentation so as to ensure the compliance of state of validation, thereby achieving the corporate quality objectives as well as the compliance of the cGMP regulations and guidelines.3,4,11,14

Validation Master Plan is expected to help management to evaluate what the validation program involves with respect to time, people, and financial resources, and to understand the necessity for the program, all members of the validation team to know their tasks and responsibilities and inspectors/auditors to understand the company’s approach and commitment towards validation and the setup of an organization of all validation activities.1,2,3,5

The Validation Master Plan shall be a live document that is expected to serve throughout the lifecycle of a project and the products, processes, methods and to some extent in case of inclusion of new products, processes, systems, methods and when new project is planned in the existing locations.4,5

However, there is always a scope for continuous development in validation approach and execution in a highly regulated industry like finished pharmaceutical products manufacturing, resulting from changes in regulations, environmental/pollution control boards, food and drug authorities’ guidelines and guidance. In such cases the Validation Master Plan shall be modified to maintain its live document status.5

And also whenever required separate validation master plans shall be prepared and effected for big projects and specialized validation requirements in line with the principles, approach and philosophy of this Validation Master Plan.4

Validation shall be a phenomenon encompassing all the organized effort of all activities, which shall be characterized by tangible deliverables like validation documentation, qualified personnel and well-maintained machine/system resources and the output of validation shall be the quality of the final product.3,12

References

1. EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines - Volume 4 of “The rules governing medicinal products in the European Union” contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EECrespectively.
2. Pharmaceutical Inspection Co-operation Scheme - Leading the international development, implementation and maintenance of harmonized GMP standards and quality systems of Inspectorates in the field of medicinal products.
3. World Health Organization (WHO) good manufacturing practices and validation for pharmaceutical products: “Good practices in production and quality control”, provides guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of QA.
9. These two parts were subsequently supplemented by further guidelines which are integral parts of these GMP for pharmaceutical products. All these texts are available on the Medicines web page (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover. html).
4. Validation-online.net – The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable current Good Manufacturing Practice (cGMP) requirements into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving,
and executing validation documentation and tasks. It must comply with all the appropriate requirements documented in 21 Code of Federal Regulation Part 11, 210, 211 and 820 legislation. All these texts are available on the web page (https://www.validationonline.
net/validation-master-plan.html).
5. Title 21--Food and Drugs Chapter I--Food and Drug Administration Department of Health and Human services subchapter c--drugs: General - Part 211 current Good Manufacturing Practice for Finished Pharmaceuticals.
6. Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. Recognized globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.
7. Saudi Food and Drug Authority - Guide to Good Manufacturing Practice for Medicinal Products - The basic concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasize their relationships and their fundamental importance to the production and control of medicinal products.
8. International Council for Harmonization (ICH) Guidance: Quality Guidance Documents.
9. Sultanate of Oman – Ministry of Health, Guidance.
10. GCC Guideline - Gulf Co-operation Council (GCC) States.
11. GAMP 4 - Guide Validation of Automated Systems [Good Automated manufacturing practice (GAMP) Guide].
12. Therapeutic Good Administration (TGA) Guidelines for Good Automated manufacturing (GMP) – To provide the Validation Master Plan. Ensure that it meets the requirements outlined in Annex 15, of the PIC/S Guide to GMP for Medicinal Products.
13. Medicine Control Council (MCC) Guidelines for Good Manufacturing Practices (GMP): 4.6.1 Validation protocols and validation master plan.
14. International Society for Pharmaceutical Engineering (ISPE) Base Line Guide for New and Renovated Facilities.
15. ISO 14644- 1: 2015: Clean rooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration.

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Published

2018-10-27

How to Cite

Pandey, M. A. G. (2018). Validation Technology in the Pharmaceutical Industry - A Review. Journal of Drug Discovery and Development ( ISSN:2581-6861), 2(1), 30-34. Retrieved from http://www.medicaljournalshouse.com/index.php/JDrug-Discovery-Development/article/view/62

Issue

Vol. 2 No. 1 (2018): Journal of Drug Discovery and Development

Section

Review Article

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