European Pharmaceutical Review

OCTOBER 3, 2024

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.

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GMPSOP

OCTOBER 26, 2022

Table of Contents What is the concept of validation in pharmaceutical industry? ” Validation is a critical concept in the pharmaceutical industry. .” ” Validation is a critical concept in the pharmaceutical industry. Additional documents included each month. All written and updated by GMP experts.

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GMPSOP

MAY 31, 2024

If you are in the pharmaceutical business, regulatory authorities mandate that you develop, implement, and periodically review a validation master plan for qualifying your systems, processes, cleaning method, testing methodologies, equipment, facilities, etc. – General guidance for validation document format. 12 or 24 months).

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Quality Matters

NOVEMBER 5, 2024

Insights from USP’s Medicine Supply Map demonstrate that geographic concentration of pharmaceutical manufacturing anywhere in the world – including within the United States – increases the risk for drug shortages. Promoting geographic diversity of the manufacturing base of U.S.

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GMPSOP

JUNE 28, 2024

Additional documents included each month. Additional documents included each month. Subscribe Different types of deviations in pharmaceuticals There are two types of deviations. This article will explore more elements of unplanned deviations than planned deviations. Additional documents included each month.

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GMPSOP

JUNE 9, 2024

From starting materials to testing pharmaceutical products coming out of the manufacturing process, quality control is the only function that detects unknown defects early and allows for timely correction. Additional documents included each month. 210 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

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GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. You must document all sampling procedures and plans in use.

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Putting Patients First Blog

APRIL 7, 2025

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

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GMPSOP

MARCH 17, 2023

Table of Contents If you are looking for literary help to write an actionable procedure on corrective and preventive action for your workplace or school, this article will be a good place to start. Additional documents included each month. Additional documents included each month. Consider this scenario. When to raise CAPA?

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GMPSOP

MARCH 20, 2024

The same principle can be applied to pharmaceutical instruments, especially those directly impacting product quality and safety. This article will discuss the general requirements for instrument calibration in production and laboratory testing, which may affect pharmaceutical products’ identity, strength, quality, or purity.

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GMPSOP

FEBRUARY 25, 2023

Table of Contents Importance of sampling in pharmaceutical industry Pharmaceutical sampling procedures are carried out during and at each major processing step during the manufacturing to ensure the highest quality is attained. Additional documents included each month. Additional documents included each month.

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GMPSOP

FEBRUARY 28, 2024

This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceutical companies must adhere to for optimal cleanliness and safety. Additional documents included each month. Additional documents included each month. Checkout sample preview s.

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GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. Equipment cleaning validation protocol was not discussed intensely in this article which was covered elsewhere in this blog. Additional documents included each month.

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GMPSOP

JUNE 15, 2025

Effective Control of Microorganisms in Pharmaceutical Manufacturing Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST The control of microorganisms in pharmaceutical production ensures that they stay at acceptable levels. Additional documents are included each month.

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Quality Matters

SEPTEMBER 15, 2023

FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Disclaimer: The article below includes a discussion of key points of the guidance document. It is not the guidance document, nor it is an alternative to the guidance document. The guidance document is available here: [link].)

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GMPSOP

DECEMBER 10, 2023

Therefore, manufacturers pay particular attention to getting the right medication and strength into the right container with the correct labels and instructions for use. Additional documents included each month. Document the results of the inspection in the batch production records. Additional documents included each month.

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GMPSOP

MAY 17, 2024

This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceutical companies must adhere to for optimal cleanliness and safety. Additional documents included each month. Additional documents included each month. Checkout sample preview s.

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GMPSOP

JULY 31, 2023

In this article, we will explore what operational qualification entails, its importance, and FDA requirements. The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products. When is equipment qualification necessary?

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Viseven

SEPTEMBER 14, 2023

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. To give you an example, a pharmaceutical manufacturer, Moderna , relies on Looker, an AI-powered data analytics solution delivered by Google.

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BioPharma Dive

JUNE 5, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.

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