INTERNAL AUDITS
Pharmaceutical manufacturers regularly conduct internal audits which is a way of verifying that all quality related activities comply with the code of GMP and with organisation’s standards. It also gives the opportunity to update any procedures and practices which may need to be improved.
There are 2 types of audits employ:
System audit: verifies that the systems work
Compliance audit: verifies that procedures and systems are in place
The local regulatory authorities also conduct audits of manufacturing sites and processes. During these audits, it is expected the organisation to continue your work as usual and, where required, answer any questions auditors. Following the audits, organisations will take any required corrective action to rectify identified deficiencies or non-conformances.
COMPLAINTS
While the manufacturer make every effort to ensure their products meet GMP and the highest quality standards, there is a possibility that an individual will make a complaint about a product’s quality, or report a defective product.
Therefore, in accordance with GMP, the pharmaceuticals manufacturer should have procedures in place to deal with:
Customer Complaint:
Negative feedback a customer regarding the product of a product or packaging, unrelated to administration to an animal or (inadvertent) administration to a human.
Customer complaints can also be described in a positive sense which can highlight a problem with a product or service.
Adverse Event:
An unintended or unexpected effect on animals, humans or the environment, including injury, sensitivity reactions or lack of efficacy associated with the clinical use of a veterinary or chemical product.
Organisation’s Complaints Procedure outlines the actions to be taken regarding complaints and adverse events, including:
1. Receipt
2. Response (including replacement samples managed by customer service)
3. Documentation
4. Evaluation
5. Management of complaint samples
6. Regulatory reporting
7. Investigation
8. Closure
9. All adverse events must be reported to the local regulatory authorities.
PRODUCT RECALLS
The Recall Procedure outlines the actions to take regarding recalls and applies to all products manufactured.
A recall may be necessary as a result of internal audit findings, investigations, customer complaints or because the quality or status of a product is determined to be questionable or unsatisfactory.
The level of a recall will depend on the adverse impact or potential adverse impact created by the use of the product. Local regulatory authority’s Recall guidelines must be used which are generally as follows:
Urgent:
Relates to recalls assessed as presenting a high risk (i.e. product defects / non-compliances that are serious or life threatening to the target species, consumers, operators or the environment).
Non-Urgent:
Relates to all recalls assessed as not presenting a high risk.
Note:
All recalled materials must be clearly marked and stored separately in restricted areas.
In summary, when the fundamentals of quality management system are adhered to ensure pharmaceutical products are safe, pure, effective and traceable for human and animal use a custom set of codes are derived which is known know as Good Manufacturing practice (GMP). They are in effect same in principles to produce best possible quality outcomes.
GMPc Vietnam is recognized throughout Vietnam as the leader in providing turnkey consulting solutions for GMP-certified facility projects, including Pharmaceuticals, Cosmetics, Health supplements and Veterinary pharmaceutical. Though 12 years of development 2011 to 2023, GMPc has implemented more than 230 GMP-certified facility projects, equaling to more than 80% of market share of the field in Vietnam. Not only do domestic customers, foreign investors also choose GMPc as their consultant when investing new factories in Vietnam, such as Kyoto Biken Vaccine Factory, Nippon Chemiphar Pharmaceutical Factory, Shimizu Contractor, Kajima Contractor, etc.
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