GMP Training

Latest version of PIC/S Released on August 2023.

• PE 009-16

• PE 009-17

• PE 009-18

• PE 009-15

Responsible in ensuring that each batch has been manufactured and checked in accordance with GMP prior batch release.

• Production Head

• QA Head

• QC Head

• Authorised Person

Who is the Authorised person of Delta Plant?

• Vren Cristobal

• Kat Maguigad

• Angela Gopez

• Sheila Diaz

A document describing the GMP related activities of the manufacturer.

• Specifications

• Site Master File

• Certificate of Analysis

• Master Formulae

Accidental inclusion of product of another batch or unknown foreign material into a finished batch.

• Out-of-specification

• Contamination

• Deviation

• Cross-contamination

Philippines is a current PIC/S Member.

• True

• False

Which Asian country is a new member of PIC/S?

• Saudi Arabia

• Indonesia

• Philippines

• Japan

PIC/S Chapter 5

• Personnel

• Quality Control

• Documentation

• Production

PIC/S stands for:

• Pharmaceutical International Co-operation Scheme

• Pharmaceutical Inspection Co-operation Scheme

• Pharmaceutical Inspection Corporation Scheme

• Pharmaceutical Inspection Co-operation Strategy

Contract Giver must able to carry out satisfactorily the work ordered by the Contract Acceptor.

• True

• False