GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. Why is change control management important in pharmaceuticals? Change control management is a critical and frequently used concept in pharmaceutical industry.

Documentation 52

Documentation Packaging Communication Customer Service 52

Putting Patients First Blog

APRIL 7, 2025

AI in Drug Discovery and Preclinical Development The integration of AI and ML into drug and biologic development presents transformative opportunities while introducing critical regulatory and ethical challenges. 3 ,4 The NHC is uniquely positioned to provide input on this issue.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

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.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

MARCH 30, 2024

Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error. .

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

GMPSOP

MARCH 17, 2023

Additional documents included each month. Subscribe Corrective action vs preventive action examples In pharmaceuticals, corrective and preventive action (CAPA), is conducted at the implementation stage of most quality concern investigations. As a preventive action, the supplier of the carton was contacted and presented the issue.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

Viseven

JANUARY 13, 2023

HEOR (Health Economics and Outcomes Research) – is a common term used for experts who collect patient and medical data that proves the real value of the product, how it can influence the quality of life of the patient, and its capacity to compete against similar products present on the market. How HEORs Contribute to Research?

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Dosage Drug Pricing 40

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.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

GMPSOP

FEBRUARY 28, 2024

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.

Documentation 98

Documentation Packaging Pharmaceutical Manufacturing Compounding 98

GMPSOP

SEPTEMBER 27, 2023

The practice of calling a piece of equipment clean just because it looks clean is not acceptable in the pharmaceutical manufacturing process. Additional documents included each month. – To conduct the validation studies in accordance with the protocols and to document the results of studies.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. Additional documents included each month. Additional documents included each month. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Checkout sample preview s.

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 52

Express Pharma

JUNE 5, 2024

Also, the proliferation of antimicrobial resistance (AMR), where overuse of antibiotics leads to resistant bacteria, making infections harder to treat Additionally, pharmaceutical manufacturing consumes substantial amounts of solvents, which are typically highly toxic chemicals, as well as heavy metals.

Pharmaceutical Manufacturing 98

Pharmaceutical Manufacturing Packaging Documentation Compounding 98

GMPSOP

DECEMBER 10, 2023

Particularly the printed packaging materials where product information is presented. 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. Checkout sample preview s.

Packaging 40

Packaging Health and Personal Care Stores Labelling Documentation 40

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.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Health and Personal Care Stores Documentation Compounding 52

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].)

Documentation 52

Documentation Compounding Pharmaceutical Manufacturing 52

GMPSOP

MAY 17, 2024

Regulatory requirements for GMP 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.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing Compounding 52

GMPSOP

JULY 31, 2023

We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.

Documentation 52

Documentation Dosage Labelling Data Entry 52

Express Pharma

JANUARY 27, 2025

Presentation highlights: The session was led by Dr Hargovind Seth, Head-QC, Windlas Biotech. He presented a comprehensive overview of the Revised Schedule M and its profound implications for materials management, vendor qualification, and reference standards.

Pharmaceutical Manufacturing 99

Pharmaceutical Manufacturing Documentation Labelling 99

FDA Law Blog: Biosimilars

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. Unapproved prescription drugs present serious safety and effectiveness concerns. Please bear with us.) FDC Act 804(j)(1), (2).

Online Pharmacies 59

Online Pharmacies Drug Pricing Documentation Pharmaceutical Manufacturing 59

BioPharma Dive

JUNE 5, 2025

Questions remain The FDA will plan to focus Elsa’s scope on administrative tasks such as summarizing documents and data extraction. The agency provided few other details regarding how Elsa was trained and how much it’s been tested. And for AI life sciences companies, Elsa’s debut may be a source of validation.

Drug Pricing 52

Drug Pricing Drug Development Vaccines Pharmaceutical Manufacturing 52