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CleaningVal9909 - Cleaning Validation in Active...

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Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants September 1999
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Guide to Cleaning Validation in API plants Table of contents 1. Foreword .................................................................................................... ..... 2 2. Objective .................................................................................................... ..... 3 3. Scope ..…… ................................................................................................ ..... 4 4. Potential residues …………………………… .................................................. 5 5. Current regulatory guidance ……………… .................................................... 6 6. Cleaning validation policy ........................................................................ ..... 7 7. Levels of cleaning .………… ..................................................................... ..... 8 8. Elements of cleaning validation ............................................................... ..... 10 8.1 Establishment of acceptance criteria… .................................................... 12 8.1.1 chemical determination ........................................................................ 12 8.1.2 physical determination ......................................................................... 13 8.1.3 microbiological determination .............................................................. 13 8.2 Cleaning procedures ............................................................................... 13 8.3 Sampling ................................................................................................ 15 8.4 Analytical methods… . ............................................................................ 16 8.5 Validation protocols ............................................................................... 17 8.6 Validation reports ................................................................................... 18 9. Minimum requirements ........... .............................................................. ..... 20 10. Change control ………… .......... .............................................................. ..... 21 11. Summary ……………… ........... .............................................................. ..... 22 12. References …………..… ........... .............................................................. ..... 23
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Guide to Cleaning Validation in API plants 2 1. Foreword This Guideline has been produced by the Active Pharmaceutical Ingredients Committee (APIC) Working group. Different organizations will be influenced by their companies and the markets that they serve in the approaches that they take and the policies that they have with respect to the subject. It is also valuable to bear in mind that this is an area that is changing rapidly and what was considered as being acceptable 2-5 years ago is now not adequate. Therefore, companies should be aware of the need to continuously update themselves on current regulatory requirements.
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Guide to Cleaning Validation in API plants 3 2. Objective The intention of this document has been to define a comprehensive approach to the Validation of Cleaning procedures in Active Pharmaceutical Ingredient manufacturing facilities. Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels. It is necessary to Validate Cleaning procedures for the following reasons: a. It is a customer requirement - it ensures the safety and purity of the product. b. It is a regulatory requirement in Active Pharmaceutical Ingredient product manufacture. c. It also assures from an internal control and compliance point of view the quality of the process.
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Guide to Cleaning Validation in API plants 4 3. Scope This Document will serve to: 1. Define the basic concepts and terms associated with Cleaning Validation in the Active Pharmaceutical Ingredient industry. 2. Serve as a guide from which Masterplans, Protocols and Reports may be compiled.
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