GMP News - Pharmaceutical Technology

19.02.20

Are Nickel-Plated Components Allowed in the GMP Area?

 The nickel plating of surfaces is a good and high-quality method to protect components or surfaces from corrosion. At the same time, the question is repeatedly asked whether components treated in this way may be used in the GMP area. Read more here.

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17.02.20

Deficiencies in Maintenance, OOS and Data Integrity lead to Warning Letter

A pharmaceutical manufacturer in India received a Warning Letter from the US-American FDA in December due to deficiencies in the areas of maintenance/cleanliness, OOS and data integrity. Read more here.

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17.02.20

Warning Letter for US Manufacturer: Issues in the Water System

A US-American pharmaceutical manufacturer received a Warning Letter from the FDA in November 2019 due to microbial issues in the water system, deficiencies in qualification/validation and insufficient stability data. Read more here.

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05.02.20

New USP Chapters regarding Testing for Subvisible Particles

The USP has published the revised chapter on testing for non-visible particles <1788> as well as new monographs on the individual test methods light obscuration, membrane microscopy and flow imaging as drafts.

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18.12.19

cGMP Qualification/Running of Water Systems

Water systems are one of the most important systems in the pharmaceutical industry. What are the GMP requirements for the qualification and running of these systems? The US GMP regulations (21 Code of Federal Regulation (CFR) 210/211) do not provide much concrete information on this. There is still a Guide to Inspection for FDA inspectors from the early 90s. So, what does the FDA expect today? A current Warning Letter provides a few answers.

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11.12.19

Warning Letter for U.S. Manufacturer due to Defects in Equipment, Stabilities and Complaints

In September, a US pharmaceutical manufacturer received a Warning Letter from the FDA due to GMP violations in the areas of equipment cleaning, drug stability and handling complaints.

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06.11.19

General requirements for Plastics in Pharmaceutical Engineering

The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?

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30.10.19

ISO Standard for the Production of Pharmaceutical Water

ISO 22519 is a new available international standard dealing with the pretreatment and the production of purified water (PW) and water for injection (WFI).

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24.10.19

Warning Letter: Deficiencies in Validation and OOS

Once again, an Indian pharmaceutical manufacturer has received a Warning Letter from the US-American FDA due to deficiencies discovered during an inspection. The Letter focuses on deficiencies in the validation and the handling of OOS results in the laboratory. Read more here

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26.09.19

Another FDA Warning Letter due to Deficiencies in the Water System

Again the US-American FDA has issued a Warning Letter which primarily describes defects in the water system as well as deficiencies in the handling of CAPA & OOS and in the cleaning.

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18.09.19

Warning Letter due to Cross Contamination

In August, the US FDA issued a Warning Letter due to cross-contamination with penicillin in areas for non-beta-lactam production.

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04.09.19

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.

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28.08.19

What are suitable Cycles for Re-Qualification?

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.

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28.08.19

Scale Calibration: Requirements of the FDA

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?

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21.08.19

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.

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