Pharmaceutical Technology

AUGUST 8, 2025

Robert Barrie August 8, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook More than half of pharmaceuticals distributed in the US are manufactured overseas. The PreCheck programme, unveiled by the FDA on 7 August 2025, comprises a two-phase approach to facilitate new US drug manufacturing facilities.

Packaging

European Pharmaceutical Review

AUGUST 23, 2022

Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.

Documentation

European Pharmaceutical Review

JULY 5, 2023

43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing. Specifically, the document covers the development process of glass containers for pharmaceutical products, glass container sampling as well as definition of lots.

Pharmaceutical Manufacturing

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

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.

Packaging

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Selecting the best pharmaceutical wholesalers. Temperature control facilities and supply solutions.

Documentation

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

GMPSOP

MAY 26, 2023

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

Documentation

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

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

Quality Matters

NOVEMBER 5, 2024

Insights from USP’s Medicine Supply Map demonstrate that geographic concentration of pharmaceutical manufacturing anywhere in the world – including within the United States – increases the risk for drug shortages. Promoting geographic diversity of the manufacturing base of U.S.

Pharmaceutical Manufacturing

Pharmaceutical Technology

SEPTEMBER 20, 2022

The information contained within the download document is intended for pharmaceutical manufacturers, wholesalers, retailers and distributors, pharmaceutical executives, medical representatives, business development managers, retail salesmen, sales managers, pharmacy executives, and any other individual involved in pharmaceutical marketing.

Documentation

Quality Matters

AUGUST 3, 2023

They comprise interconnected webs of local and global ingredient suppliers, manufacturers, packagers, distributors, providers, and regulators. active ingredients, excipients, other raw materials) Packaging materials (e.g., Global supply chains are complex and vulnerable to disruption.

Packaging

GMPSOP

MAY 31, 2024

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.

Documentation

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

GMPSOP

JUNE 28, 2024

Additional documents included each month. Adulterated Pharmaceuticals: 396 warnings iii. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Additional documents included each month. Checkout sample preview s.

Documentation

pharmaphorum

OCTOBER 27, 2022

The rationale for engaging with certain influencers and digital opinion leaders should be considered and documented. The post New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry appeared first on. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates.

Communication

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. Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)? Subscribe Step 1.

Documentation

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. These are called primary packaging materials. Additional documents included each month.

Labelling

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. The entire unused packaging lot which was quarantined was returned to the supplier.

Documentation

GMPSOP

MARCH 8, 2024

– Please make sure that proper documentation is maintained and corrective action is undertaken. The FDA subsequently published several guidance documents regarding this matter. Additional documents included each month. Additional documents included each month. Additional documents included each month.

Documentation

GMPSOP

AUGUST 14, 2023

Packaging lines are fully automated and working without any hiccups. Additional documents included each month. The results of the periodic review must be documented, reviewed, and approved by the site validation committee. You should take a procedural approach to document the outcome of the review.

Documentation

GMPSOP

AUGUST 7, 2023

Additional documents included each month. Additional documents included each month. Measurement planes consist of series of taps (traverse points) located around the perimeter of duct or on the vertical sides of a central station air handling unit, packaged air conditioning unit or plenum. All written and updated by GMP experts.

Documentation

GMPSOP

DECEMBER 10, 2023

Particularly the printed packaging materials where product information is presented. Printed packaging materials typically include product names, active ingredients, concentration, batch numbers, expiry dates, registration numbers, barcodes, etc. Commonly used packaging materials are cartons, inserts, leaflets, printed foil, etc.

Packaging

GMPSOP

APRIL 3, 2024

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. Therefore, GMP rules ensure that materials are handled and stored properly and that appropriate documentation is maintained. Checkout sample preview s.

Labelling

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

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

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

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

Pharmaceutical Technology

MARCH 10, 2023

The list also includes manufacturers and suppliers of biological safety cabinets, clean benches, nanotechnology enclosures, drying chambers, vacuum pumps, filters, remote blowers and exhausters, loading and unloading systems as well as controlling and monitoring systems.

Documentation

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

Viseven

SEPTEMBER 14, 2023

For example, a pharmaceutical brand can face increased acquisition costs if a supplier has not delivered on time. It also bears extra replacement expenses when drugs are discarded due to improper packaging. Technologies allow pharmaceutical companies to collect and analyze a massive amount of data to ensure proper drug safety.

Packaging

GMPSOP

MARCH 6, 2025

Rework procedure in pharmaceutical manufacturing Step-by-step guide Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST A rework procedure is a structured way of correcting quality defects identified in a batch or number of batches of pharmaceutical products.

Pharmaceutical Manufacturing