PTC Therapeutics, a US pharmaceutical company, plans to expand its European headquarters in Dublin to 40 staff.
The Dublin site of the company is responsible for finance, quality assurance, legal and a raft of other back office roles.
“We currently employ 30 people in the Dublin office and this will increase to a total of 40 sustainable jobs in this office within a short period of time,” said Adrian Haigh, who heads up the company’s international operations.
PTC focuses on the discovery and commercialisation of novel medicines. It has been working on the development of a drug called Translarna for almost 20 years. The drug is the only protein restoration therapy for the treatment of nonsense mutation Duchenne Muscular Dystrophy – a genetic disorder characterised by progressive muscle degeneration.
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We can understand pharmaceutical production batch record review as meaning the controls and processes that pharmaceutical organizations have to build into the batch records of pharmaceutical products they manufacture. This is a means to ensuring that products meet compliance standards and are easy to detect whenever a problem arises from a sample in the batch or in the entire batch.
What does the 21 CFR 211.100 (a) say?
21 CFR 211.100 (a) is clear in its expectations. This and related subsections lay out the process by which pharmaceutical production batch record review has to be done. It states that all requirements have to written down in a prescribed format. The aim is to ensure that the core qualities of the drug relating to its molecule, such as the strength, quality, purity and identity are adhered to in every batch.
The World Health Organization (WHO) lists the requirements for pharmaceutical production batch record review. These are the main points that go into it:
Pharmaceutical production batch record review consists of reviewing production and quality control records being made part of the approval process of batch release. Whenever there is the slightest deviation or failure on the part of any batch to meet its specifications; this should be properly and completely investigated. To ensure the quality of pharmaceutical production batch record review; the WHO states that the investigation can extend to other batches of the same product if necessary. On any observation and action taken, there should be a written record created of the investigation. This record should include the conclusion and details of the follow-up action that was taken.
The WHO also states that retention samples from each batch of finished product should be kept for at least one year after the expiry date. These have to be kept in the prescribed methods and conditions. Pharmaceutical production batch record review requirements state that where starting materials are concerned, the retention period is two years from the date of expiry.
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