Validation

Process Validation Guidances: FDA and Global

Process Validation Guidances: FDA and Global   OUTLINE Process Validation Lifecycle Approach Overview History and development Is the lifecycle approach really new? FDA commentary Lifecycle Approach Stages 1 — Process Understanding (Process Design) 2 — Process Demonstration (Process Qualification) 3 — Maintaining Validation (Continued Process Verification) Fundamental Concepts The “process …

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Establishment of Limits in Cleaning Validation

Establishment of Limits in Cleaning Validation The  rationale for selecting limits for product residues should be logical and based on the materials involved and their therapeutic dose. The limits should be practical, achievable, and verifiable. In establishing product residual limits, it may not be adequate to focus only on the …

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Sampling, Rinsing, Rinse Samples and Detergents in cleaning Validation

Sampling, Rinsing, Rinse Samples and Detergents in cleaning Validation Sampling: There are two general types of sampling that are considered to be acceptable, direct surface sampling (swab method) and indirect sampling (use of rinse solutions). A combination of the two methods is generally the most desirable, particularly in circumstances where …

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Documentation in cleaning validation

Documentation in cleaning validation 1.0 Detailed cleaning procedure(s) are to be documented in SOPs 2.0 A Cleaning Validation Protocol is required to define how the cleaning process will be validated. It should include the following: The objective of the validation process; Responsibilities for performing and approving the validation study; Description …

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Validation of Cleaning Processes

Validation of Cleaning Processes  As a general concept, until the validation of the cleaning procedure has been completed, the product contact equipment should be dedicated. In a multi-product facility, the effort of validating the cleaning of a specific piece of equipment which has been exposed to a product and the …

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Levels of Cleaning in cleaning Validation

Levels of Cleaning in cleaning Validation Introduction The manufacturing process of an Active Pharmaceutical Ingredient (API) typically consists of various chemical reaction and purification steps followed by physical changes. In general, early steps undergo further processing and purification and so potential carryover of the previous product would be removed. The level of cleaning …

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Validation of Sterilization Process in Autoclave

Validation of Sterilization Process in Autoclave VALIDATION PROTOCOL                  Validation of Sterilization  Process in Autoclave (Loaded chamber)  Purpose : To provide the procedures to be followed for study of heat  distribution studies in loaded chamber of Autoclave.  Scope :  This procedure is applies to all Autoclaves used to sterilize Containers or Equipment’s …

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Prospective Process Validation

Prospective Process Validation I. INTRODUCTION Validation is an essential procedure that demonstrates that a manufacturing process operating under defined standard conditions is capable of consistently producing a product that meets the established product specifications. Process validation is establishing documented evidence that provides a high degree of assurance that a specific process  will …

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Cleaning Validation Protocol

Cleaning Validation Protocol CONTENTS S. No. Topic Page No. 1.0 Protocol Preparation and Approval Sheet 2.0 Objective 3.0 Scope 4.0 Responsibility 5.0 Validation Team 6.0 Abbreviations and Definitions 7.0 Cleaning Validation Approach 7.1 Selection of Products 7.2 Selection of Equipments 7.3 Type  Cleaning after every five consecutive batches of the …

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Template for Process validation protocol

Template for Process validation protocol Objective To provide documented evidence with high degree of assurance that the manufacturing process is capable of producing the finished product consistently of required quality, meeting its predetermined specifications and quality attributes. Scope   This process validation protocol is applicable to carry out process validation …

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