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

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

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

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

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

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

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

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

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

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

Express Pharma

DECEMBER 23, 2024

He presented on good practices in quality control, highlighting the importance of appropriate qualifications and experience, and adequate facilities for storage and sampling. He mentioned the necessity of having license number, and manufacturer address on certificates of analysis.

Documentation 104

Documentation Method Validation Pharmaceutical Manufacturing Packaging 104