Remove Document Remove Labelling Remove Pharmaceutical Manufacturing
article thumbnail

Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

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.

article thumbnail

Line clearance procedure and reconciliation in GMP

GMPSOP

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Leading pharmaceutical wholesalers

Pharmaceutical Technology

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.

article thumbnail

Steps required to control packaging materials in pharmaceutical

GMPSOP

Packaging and labelling mix-ups can potentially result in serious health consequences. Accurate labelling of medicines is critical to patient health. Therefore, manufacturers pay particular attention to getting the right medication and strength into the right container with the correct labels and instructions for use.

article thumbnail

Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

But the new Joint Guidance on Virtual and Hybrid International Medical Congresses, from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) is here to plug that gap.

article thumbnail

Overview of pharmaceutical quality control steps and implementations

GMPSOP

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

article thumbnail

GMP rules to keep pharmaceutical warehouse in perfect condition

GMPSOP

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.