EMA website on Permitted Daily Exposure (PDE) limits
The issue of cross-contamination has been addressed by authorities since the publication of the first edition of the EU GMP Guidelines. The EMA has compiled everything essential on health-based exposure limits and PDE limits on their website.
New Ph. Eur. chapter on statistical process control (SPC) planned
Process controls have become customary in pharmaceutical processes. The aim is to monitor a process and improve it if possible. Statistical process control (SPC) is viewed as one option to implement Ongoing/Continued Process Verification. PharmEuropa has now published a new draft chapter on the topic.
Fundamental GMP Deficiencies at US-American Pharmaceutical Manufacturer
During the inspection of a pharmaceutical manufacturer in the USA, the FDA discovered fundamental GMP deficiencies which concern - among other things - cleaning of equipment, cleaning validation, the water system and the stability programme.
With the revision of Annex 15 in October 2015, the topic of requalification has become more important. Time intervals for the assessment of the equipment with regard to the qualification status and for the requalification itself should be justified. Criteria for the assessment should be defined. This is sometimes difficult. Chapter 9 of the revised ISPE Baseline No 5 Commissioning & Qualification of June 2019 on the periodic review can be helpful here.
The GMP regulations do not provide any concrete specifications for the calibration of weighing instruments. They refer to suitable measuring and weighing ranges and the required accuracy. Regular maintenance and calibration are also required. So how can these general formulations be interpreted?
Warning Letter due to Deficiencies in the Purified Water System
In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.
ISPE publishes revised Guideline on Commissioning and Qualification
The ISPE Baseline Guide Vol. 5 on Commissioning & Qualification has been in place since 2001 and was thus no longer up to date. Recent developments, e.g. towards a lifecycle model, were not reflected in the document. Now the ISPE Baseline Guide Vol. 5 has been completely revised.
Regulations concerning the handling and management of data from "small" computerised systems?
The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 5: Are regulations necessary for the handling and management of data generated by small systems (e.g. pH meters, filter integrity testers, etc.)?
What is considered GMP-compliant equipment design?
It's a frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP-compliant equipment design.
WHO publishes Draft Guideline on Production of WFI using Non-Distillation Methods
The WHO has reacted to the changes in the European Pharmacopoeia by issuing a draft guideline on the production of WFI (Water for Injection). The commentary phase is open to the public, comments can be submitted until 20 September 2019.
cGMP Cleaning Validation - FDA's Current Requirements
What do authorities require regarding cleaning validation? Official GMP inspection reports deliver helpful answers to this question. Through the Freedom of Information Act, the FDA is required to publish inspection results. This is particularly the case with Warning Letters. Here, even details of deficiencies regarding cleaning validation are included in the Warning Letter.
What are the authorities' requirements regarding process validation? Regulatory GMP inspection reports are useful in answering that question. The "Freedom of Information Act" obliges the US FDA to publish all inspection results. The FDA does that particularly when it comes to warning letters.
Ensuring the data integrity of cloud service providers
The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 3: What agreements need to be included in contracts with cloud service providers in order to ensure data integrity?