Production

HANDLING COUNTERFEIT/FALSIFIED MATERIALS

HANDLING COUNTERFEIT/FALSIFIED MATERIALS

To lay down a standard procedure that describes handling counterfeit/falsified materials.

Applicable for the procedure of handling counterfeit/falsified materials.

PROCEDURE

The received material should undergo incoming inspection.

If the incoming inspection results of the materials are unsatisfactory, the QA department initiates the investigation of the case.

The Authorized person prepares a report on the identified defects.

Report’s copy is sent to the regional government service that takes samples for testing and takes measures for informing other parties.

The material is placed in the “HOLD” area.

If the investigation results confirm the counterfeit/falsified material, further actions are to be taken according to the order of the government authority and the conditions of the contract with the vendor in effect.

Alvina

Alvina is the Author and founder of Guidelinepharma, she is a pharmaceutical professional having more than 20 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube