Express Pharma

MAY 22, 2023

As the experts at this round table also discussed the need for such a centralised body, Srivastava, who was part of a meeting held by the Nutraceutical Task Force, informed that the formation of a nutraceutical panel in the Ministry of Commerce to ensure a nutraceutical industry-specific agenda is underway.

Dosage 105

Dosage Method Validation Labelling Immunity 105

GMPSOP

APRIL 3, 2023

– Documentation of all reagents and materials used in the laboratory, including lot numbers, expiration dates, and supplier information. Protocols are only used for specific projects such as method validation testing or equipment qualification. – References used to develop the laboratory protocol.

Documentation 52

Documentation Method Validation Compounding Data Entry 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 40

Documentation Method Validation Packaging Data Entry 40

GMPSOP

NOVEMBER 15, 2024

It should have the minimum information, such as general product information, specifications and test methodology, results, data analysis and estimated shelf life. With the appropriate detector sensitivity, column, and mobile phase, stability-indicating methods are very useful for determining degradant concentrations.

Packaging 59

Packaging Dosage Documentation Labelling 59

GMPSOP

JUNE 16, 2023

In this option, the RL has to assess all the risks and mitigate those risks by repeating the test parameters and matching the results against the original validation data. It’s essential to review the TL’s validation approach in accordance with current ICH Q2 guidelines and ensure that it covers the intended use of the method.

Documentation 52

Documentation Dosage Communication Method Validation 52

GMPSOP

NOVEMBER 19, 2023

All validation/qualification studies commenced or completed during the review period must be assessed. The effectiveness of the validation must be determined.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

GMPSOP

JULY 23, 2023

You must record all important information, including test data, observations, conclusions, etc. The information may be available in a manual but it may need to be tailored to the protocol. Provide installation qualification methodology to be used State how the validation study will meet site and cGMP requirements.

Documentation 52

Documentation Method Validation Packaging Labelling 52

GMPSOP

MARCH 4, 2023

If my cleaning methods are not validated would they cause contamination of my products? What is the probability my cleaning methods weren’t validated? Should I implement a more robust cleaning method validation to mitigate such risk? Do I have adequate control in place? How do you Identify risk?

Documentation 52

Documentation Communication Method Validation Packaging 52

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

Documentation 71

Documentation Labelling Method Validation Communication 71