It has become apparent that the greatest causes of recalls in the pharmaceutical industry are the faults in purchased products, not the medication itself
Wrong labels, printing errors on packages and errors on the patient leaflets, resulting from ineffective implementation of PS 9000 and PS 9100, the standards for pharmaceutical packaging and excipients, all contribute to the level of extensive recalls.
While the pharmaceutical industry itself is subject to regular and intense scrutiny by the regulators, its suppliers do not come under this statutory control.
It is the responsibility of the pharmaceutical company to ensure that its suppliers meet the right standards, by sending teams of auditors on visits to the suppliers.
In the absence of standards other than the industry's own GMP (good manufacturing practice), the results have often been inconsistent.
Hence many companies are turning to pharmaceutical auditor/lead auditor trainings to ensure the provision of properly skilled auditors who can successfully carry out structured and meaningful assessments.
TUV International UK has teamed up with established training providers to deliver complementary training against PS 9000 and PS 9100, the standards for pharmaceutical packaging and excipients, all contribute to the level of extensive recalls.
The next course will take place on 4 September 2006.
The IRCA-approved event is run by two certified QMS and PS 9000 auditors with third party auditing experience.
The trainers use a variety of methods from tutorials to practical workshops to provide information on the requirements and application of the standards and instruction of carrying out in-depth audits against them.
