General thoughts for the analytical method validation process

The development and production of drugs within the pharmaceutical industry requires manufacturers to quantify their components, and this entails the use of an analytical method that must first be validated in order to be implemented. Validation refers to documented evidence that a process is suitable ...

Cleaning Validation Pillars “part 1”

1. Pre-Requisites to Begin Cleaning Validation 1.1. Cleaning Validation Strategy and Protocols are approved. 1.2. Equipment used for most of the products should be identified 1.3. SOP for Equipment Cleaning has been established (draft) 1.4. Sampling and Analytical Methods are validated 1.5. A list of ...

Principles of Validation

Quality, safety, and efficacy can be summed up as the three validation principles in product design and construction. Inspection of the finished product and work-in progress are insufficient for quality assurance. The production process is reviewed at each stage to ensure that the final product meets ...

Definitions of Validation

Validation is defined as per various bodies EC, ICH, FDA, WHO as given below: According to European Commission 1991: Validation-“Act of proving, in accordance of GMPs that Any…” process actually leads to expected results. 2000: “Documented evidence that the process, operated within established ...

Validation Protocol and its Contents

A written plan stating, how validation will be conducted and defining acceptance criteria e.g: The protocol for manufacturing process identifies process equipments, critical process parameters, and / or operating range, product characteristics, sampling, test data to be collected, number of validations ...

The Role of Cleaning Validation in the Pharmaceutical Industry

In the Pharmaceutical Industry there is some possibility of contamination and cross-contamination of products due to inadequate washing of shared facilities. This can lead to severe hazards for the patient, therefore any contamination as well as cross-contamination cannot be afforded in (imagine, for ...

Why Cleaning Validation is Important?

The main purpose of Cleaning Validation is to prove the effectiveness and consistency of cleaning in a given pharmaceutical production and packaging equipment, to prevent cross-contamination and adulteration of drug products with other active ingredients (APIs) or microbiological contamination. The goal ...

Benefits/Importance of Validation

• Quality. • Customer—patient satisfaction. • It has been built into the product. • Assurance of quality. • Time bound. • Process optimization. • Reduction of quality cost. • Nominal mix-ups, and bottle necks. • Minimal batch failures leads to improved efficiency and productivity. • ...

Test parameters in the nitrogen gas validation

Test parameters during validation and its frequency are given below: a) Test for oil mists – Every 6 months once b) Test for moisture content – Every 6 months once c) Particulate count (Non-viable) – Every 6 months once d) Sterility test (Aseptic area locations) – Every 6 months ...

Applications of Equipment Validation

The following are the importance of equipment validation in pharmaceutical industries: • By minimizing rejects, reworks, and downtime, as well as by reducing the risk of regulatory non-compliance, equipment validation reduces costs. • Customer happiness is really high. • Testing and calibrations ...
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