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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.

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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.

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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.

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Leading commercial packaging companies in contract marketing

Pharmaceutical Technology

The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.

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Six steps process to implement change control management

GMPSOP

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.

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Six steps process to implement change control management

GMPSOP

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.

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How to use quality risk management in validation testing

GMPSOP

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.