[Stability Testing related News – vol.37]

◆  PIC/S implements EU-GDP for APIs (02-Aug-18 ECA)

The PIC/S* adopts the Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1). It transposes the EU Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use for PIC/S purposes. According to a PIC/ news, this “adoption further strengthens harmonisation between PIC/S and the EU”. The guidelines are more or less the same with some minor editorial differences.

Will PIC/S countries (like for example the US) now have to implement EU GDP?

According to the PIC/S GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICE OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE, “it is up to each PIC/S Participating Authority to decide whether it should become a legally-binding standard.”

*The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 52 participating authorities coming from Europe, Africa, America, Asia and Australasia.

◆  Successful ECA, USP and EDQM Joint Conference on Glass packagings (15-Aug-18 ECA)

Together with the industry, the pharmacopeias are currently working on new approaches for the inner surface hydrolytic test and the light transmission test (for amber glass). Additionally, efforts are being made to develop a new description of the autoclave procedure for the glass grains and the surface tests to eliminate ongoing questions associated with the autoclave cycle and to establish a global standard.

At the USP – Ph. Eur. – ECA Joint Conference GLASS meets PHARMA from 6-7 June 2018 in Berlin, Germany, the latest news regarding glass packaging were presented by 13 speakers from FDA, EDQM, USP and Industry, including:

• An Update of USP General Chapters <660>, <1660>, including proposed revisions regarding the hydrolytic resistance test and the light transmission test
• An Update of Ph. Eur. Chapter 3.2.1 (specific topics: delamination / hydrolytic resistance)
• Glass Delamination (What is delamination – What‘s it like?) and Product Recalls caused by Delamination
• Glass Particles (Particle Contamination in Parenterals) including USP´s approach to glass particulates: Proposed New General Chapter <667> Sub-Visible and Visible Particulates in Packaging and Manufacturing Components and Systems
• Risk Evaluation of Elemental Impurities (EIs) from Glass in view of ICH Q3D and mitigation strategies to reduce extractables with surface treatment and coatings (for example by siliconization of the container inner surface)
• Glass formulations with enhanced chemical stability – for example Aluminosilicate glass (e.g. Valor Glass®) which is not covered by the pharmacopoeias yet.
• New approaches to prevent breakage in filling lines using an innovative technology (SmartSkin©) in regard to:

1. The identification of process steps with high (mechanical) stresses,
2. The optimization of process / filling line,
3. The increase in product yield through reduction of defect rates.

These topics were highly discussed by the audience and the participant´s comments will now be considered during the revision process of the pharmacopoeias regarding the chapters on glass packaging materials.

◆  New Q&As on Chapter 3 of the EU-GDP Practice Guide (Premises and Equipment) (25-Sep-18 ECA)

On the GDP Association Webpage a section has been set up a while ago dealing with frequently asked questions (FAQs). Now a set of new FAQs has been published about Chapter 3 on Premises and Equipment.

For example, answers to the following questions are provided:

• Which products can be stored in the warehouse with segregation based on a computerised system? And which products do need physical segregation?
• How can receiving and dispatch bays be designed to protect products from prevailing weather conditions?
• For premises and storage facilities, adequate cleaning programmes should be in place. How can this be realised?
• Can I take personal medication into the storage area?
• Where should we put temperature monitoring equipment?
• What is “key equipment“?

Answers to these and other questions are provided in the FAQs on GDP.