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. Kazi holds several pharmaceutical industry certifications including post-graduate degrees in Engineering Management and Business Administration. Why is cleaning validation required?

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

GMPSOP

MARCH 8, 2024

Pharmaceutical manufacturers must have written procedures on the steps to take when any result does not meet specifications. To replace the single invalidated result, you should test one additional dosage unit for the content uniformity test or perform a dissolution test using one dosage unit.

Documentation 52

Documentation Dosage Pharmaceutical Manufacturing Packaging 52

GMPSOP

OCTOBER 28, 2023

Quality is everyone’s responsibility, and it should pervade every aspect of pharmaceutical manufacture and packaging. Quality should not be tested into products; instead, it must be built in at each step of manufacture. Pharmaceutical manufacturers must integrate the key functions of the quality control process.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. Combining methods of coding for both end solutions has, in the past, been the biggest challenge. .

Packaging 40

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

GMPSOP

JUNE 9, 2024

Name, source, manufacturing sites, and date of manufacture of drug substance) – Dosage form and strength, including formulation – Composition, type, source, size of container, and closure – Specifications and test methodology (I.e., – Routine recording of environmental parameters (e.g.,

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

GMPSOP

JULY 31, 2023

The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.

Documentation 52

Documentation Dosage Labelling Data Entry 52

Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. Within the small molecule landscape, several trends are shaping the industry’s future, one of the most notable being the rise of high-potency active pharmaceutical ingredients (HPAPIs).

Drug Development 52

Drug Development Dosage Pharmaceutical Manufacturing Communication 52

Pharmaceutical Technology

FEBRUARY 3, 2023

Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.

Dosage 52

Dosage Pharmaceutical Manufacturing Packaging Communication 52