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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.

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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

He also discussed the importance of having retention samples for raw materials and packaging materials and the role of quality control in investigating deviations and ensuring the stability of raw materials. The panel also discussed the role of analytical method validation when outsourcing testing and the necessity of Excel sheet validation.

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Concept of validation in pharmaceutical industry

GMPSOP

In general, you must formally validate all process steps, production equipment, cleaning methods, testing methods, computer systems and environment, facilities and utilities which are directly used for the manufacture of sterile and non-sterile products. This validation is relatively less comprehensive.

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Validation master plan (VMP) – when and how to create one?

GMPSOP

Following are some examples of validation studies which should be included in the validation master plan: 1. Process validation master plan The process validation master plan accounts for all manufacturing and packaging processes directly employed in the manufacturing and packaging registered products.

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How to conduct product quality review in pharmaceutical

GMPSOP

Component quality A review of all starting materials and primary packaging in contact with the product should be completed. This will include supplier performance assessment and identifying any critical deviations associated with active or excipient ingredients, primary packaging and closure material. Subscribe f.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.

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Stability testing overview for Pharmaceutical products

GMPSOP

Stability testing overview for Pharmaceutical products Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Pharmaceutical products must maintain quality, safety, purity and efficacy throughout their specified shelf-life conditions up to their nominated expiration date.