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.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

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.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed for effectiveness, and communicated to a larger audience. Why is change control management important in pharmaceuticals?

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed effectiveness, and communicated to a larger audience. Why is change control management important in pharmaceuticals?

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

AUGUST 23, 2022

Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Additional documents included each month. Additional documents included each month. Assessing validation failures/deviations 4. All written and updated by GMP experts.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

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.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

MARCH 17, 2023

Immediately communicate the incident to stakeholders and initiate an internal laboratory investigation. Additional documents included each month. Additional documents included each month. The Regulatory Department is responsible for recording of changes to documented procedures resulting from corrective and preventative action.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

Quality Matters

AUGUST 3, 2023

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. Senior Director, General Chapters Global Science and Standards Division.

Packaging 52

Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

Ramblings of a pharmacist

SEPTEMBER 26, 2023

As I’ve discussed before on this blog, counterfeit products DO exist and even have the apparently appropriate T3 documents to validate their legitimacy. The communications I have seen and heard from the big 3 to small dispensers are irresponsible and seem like attempts to sabotage compliance, in my view.

Communication 105

Communication Pharmaceutical Manufacturing Documentation 105

GMPSOP

MARCH 20, 2024

Additional documents included each month. Additional documents included each month. SOP for instrument calibration: Instrument calibration is important for pharmaceutical manufacturing standards. Could you document the process in the instrument calibration register and the instrument history file? Subscribe f.

Documentation 52

Documentation Pharmaceutical Manufacturing Labelling Communication 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. Additional documents included each month. All written and updated by GMP experts.

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 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

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.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Dosage 52

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. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.)

Online Pharmacies 59

Online Pharmacies Drug Pricing Documentation Pharmaceutical Manufacturing 59