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Effective Control of Microorganisms in Pharmaceutical Manufacturing

GMPSOP

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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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 3

Express Pharma

Archive design basis documents for all facility, process, and utility decisions. Treat each deviation, complaint, or EM excursion as a rehearsal for an FDA discussion – document decisions, risk rationales, and CAPAs with inspection-grade clarity. Regularly conduct mock inspections using external or cross-site auditors.

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

GMPSOP

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.

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Overview of pharmaceutical quality control steps and implementations

GMPSOP

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

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What are the elements of quality control process in pharmaceuticals

GMPSOP

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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Supplier qualification standard aims to strengthen supply chains for quality medicines, dietary supplements, and foods

Quality Matters

While focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients.

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Basic cleaning and sanitation practices in Pharmaceuticals

GMPSOP

Regulatory requirements for cleaning and sanitation in pharmaceuticals For more than a few decades, it has been an essential GMP requirement that all cleaning and sanitation steps in a pharmaceutical plant be documented accurately and validated to prove they work. Additional documents included each month.