European Pharmaceutical Review

JANUARY 25, 2024

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.

Documentation 98

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GMPSOP

MAY 31, 2024

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.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

GMPSOP

NOVEMBER 15, 2024

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.

Packaging 59

Packaging Dosage Documentation Labelling 59

GMPSOP

OCTOBER 26, 2022

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.

Documentation 52

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GMPSOP

NOVEMBER 19, 2023

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.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

GMPSOP

OCTOBER 28, 2023

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.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

DECEMBER 24, 2023

Laboratory documentation and records that should be available include: – Test methods and test reports – Laboratory notebooks/sheets, instrument records, and calculations – Conditions of tests and instrument settings. – Test method validation protocols, data and reports – Other records and data i.

Documentation 52

Documentation Method Validation Packaging Data Entry 52