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TOP 5 GMP Downloads

1. GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

 

2. Quality Agreement
Standard draft to adapt and extend

 

3. Premises
Official requirements | material flow | room classes | and much more...

 

4. GMP Audit Checklist
for Pharmaceutical and API Manufacturers

 

5. Documenting Process Validation
A Drugmaker‘s Guide – step-by-step manual based on real-world examination experience

 

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News about GMP/cGMP

2014-10-28

This month the EMA released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”. It aims to clarify some of the expectations of EU competent authorities arising from the guidance found in ICH Q11 regarding the information to be submitted in marketing authorisation dossiers to justify the selection of starting materials.

 
2014-10-28

On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”. Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems. The guidance intends to clarify how the law under Section 707 of FDASIA (Food and Drug Administration Safety and Innovation Act) will be interpreted and put into practice by the FDA.

 
2014-10-21

The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. According to the ICH this new document shall provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the lifecycle of a product.

 
2014-10-13

The World Health Organization (WHO) has published the revised draft of the Supplementary Guideline on Good Manufacturing Practices: Validation Appendix 7: Non-sterile Process Validation.

 
2014-10-06

A new webpage has just been launched under the Certification of Suitability section of the website.

 
2014-09-26

The application forms for requests for certificates of suitability (CEPs) have been updated.

 
2014-09-26

Shortly before the next PIC/S Committee Meeting on 20-21 October 2014 in Paris, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) applied for PIC/S membership.

 
2014-09-23

The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe.

From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM. Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines.

 

 
 
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