Deviations and CAPAs are still hotly debated topics in GMP inspections. This is shown once again by a recent FDA Warning Letter.
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?
Besides several Quality Unit related failures, a Warning Letter of the U.S. FDA mentions an enormous number of Data Integrity violations. Here you can read the remedations expected by the FDA.
A revision of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa.
ISO 22519 is a new available international standard dealing with the pretreatment and the production of purified water (PW) and water for injection (WFI).
Nitrosamines have already been detected in a large number of medicinal products. Where do they come from and how are they transferred to the final product? Read more here about the causes for nitrosamine impurities that have already been identified and what should absolutely be taken into account in the risk assessment of medicinal products.
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
The Ph. Eur. provided a sample monograph to clearly show which information is included in and how to work with a Ph. Eur. monograph.
MHRA gives further guidance for a new Responsible Person function, the RPi - Responsible Person (import).
FDA announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product-Compliance Policy".