GMP News - Pharmaceutical Technology


WHO publishes draft guideline for HVAC systems for non-sterile pharmaceutical dosage forms

The WHO published a revised working document of the guideline which specifically addresses the requirements for HVAC systems used during the manufacture of non-sterile pharmaceutical dosage forms for public consultation in September.



USP wants to considerably expand the Monograph for Ophthalmic Preparations <771>

In the Pharmacopeial Forum 41(5), September 2015, the USP published a detailed draft revision of the monograph for ophthalmic preparations <771>.



Are Metal Detectors mandatory in Tableting?

The European Medicines Agency (EMA) maintains a site with answers to frequently asked questions regarding GMP. This has been updated this year and now also comprises the question about the use of metal detectors in tableting.



Exceeding the AQL Limits in the 100% visual Inspection

In addition to trending the results of the 100% visual inspection, inspection of AQL random samples has been established as part of the batch release process. But what happens if the limits in the AQL test are exceeded?



Number of samples in PQ/validation of a fully automated 100% visual inspection system

The performance qualification (PQ) or analogously to the validation, a fully automated inspection system in the 100% visual inspection, is carried out by comparing humans and machines. The intention is to show that machine inspections are not worse than human ones. But what number of test samples in PQ/validation of a fully automated (100%) visual inspection is required for a valid comparison?



New FDA Guidance for Industry on the Allowable Excess Volume in Injectable Drug Products

Usually, small volume ampules or vials for injectable drug products are slightly overfilled in order to guarantee the excess volume. Now, the FDA has made its position clear. Read more about the actual Guidance for Industry "Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products".



WHO publishes final Guideline for Hold-Time Studies

After the WHO had released the second draft of the guideline for the design of hold time studies in March already, it now released the final version as part of the Technical Report Series 992. Find out more about the Guideline for Hold Time Studies.



The Truth about the 3D/6D Rule

The installation of pipework leads to recurrent discussions about how dead legs can be prevented and about the maximum length of outgoing pipes. In most cases the 3D/6D rule is used as an argument, but not always in a correct way. Learn more about the 3D/6D rule.



Time Intervals for the recurrent Control of Clean Room Parameters

The VDI published the standard 2083, part 2 final in April. In principle, this standard summarises the requirements on clean rooms according to VDI 2083 part 1and 3 as well as DIN EN ISO 14644-1 and -3 together and indicates the time intervals at which compliance with the requirements should be checked. Read more about VDI 2083 part 2.



PIC/S takes over new Annex 15 on Validation/Qualification

Mid of April PIC/S has taken over the revised Annex 15 of the EU GMP Guide on Validation and Qualification in their GMP Guide. Learn more about the PIC/S takeover of Annex 15.



Will WFI from membrane-based technologies now become an alternative for Europe?

In an EDQM paper published in March 2015 the topic production of WFI by means of membrane-based technologies is discussed again and not excluded any more. Read more about WFI from membrane-based technologies.



New ZLG-Aide Mémoire for the supervision of sterile manufacturers

The ZLG in Germany has published a new Aide Mémoire recently that provides inspectors with a guideline for the supervision of sterile manufacturers. Read more about the content of this New ZLG- Aide Mémoire for the supervision of sterile manufacturers.



Ozonization of Pharmaceutical Water and the Biocidal Products Regulation

With the new biocidal products regulation from 2013 in-situ generated ozone now also falls into the scope of this directive. Ozone generation systems with a biocide application (such as disinfection of pharma water) thus require an approval after the transitional period expires in the September 2017. The ozone registration group is active for this purpose. Read more about the Ozonization of Pharmaceutical Water and the Biocidal Products Regulation.



Clean room concepts and their impacts on the HVAC technology

When the layout is developed, in other words when the decision is taken which processes will be carried out in which premises and how the future flows of personnel and material will take place the dimensions of the required HVAC system will also be determined. This is a new point of view in times of increasing energy costs and of the need to reduce CO2 emissions. Read more about the clean room concepts and their impact on the HVAC technology.



Is there a difference between pure and clean steam?

In the operating routine the expressions pure steam as well as clean steam are used repeatedly. But it is seldom clear whether the same is meant with these two expressions. Is there a difference at all between them? Find out more about the Difference between pure steam and clean steam.


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