Introduction

l  Quality Control Laboratory was established in 1992, independent from the production to monitor the quality of biological products produced by NIH, Islamabad.

l  At Present QCL have 35 staff members with 16 technical experts having M. Phil, M.Sc, B.Sc and Medical Technology Degrees in different biological and chemistry disciplines.

l  Quality Control Laboratory is capable of evaluating all aspects of the testing procedures and processes and performing quality control testing according to cGLP of all products for evaluating their safety and efficacy.

Objectives

• Quality Control Laboratory is responsible for establishing procedures for assuring that vaccines or biological products are of adequate safety and efficacy.

• Quality Control Laboratory is responsible for the quality and integrity of the analytical results and the associated reliability.

• Sampling and testing of Raw Materials, Packaging Materials.

• Analysis of bulk and finished products of vaccines, sera and ORS (Nimkol).

• Sampling and testing of raw water, purified water and WFI.

• Tissue Culture maintenance and preparation for testing of vaccines.

• Preparation of Batch Analysis Record (BAR) for Lot release of products from National Regulatory Authorities (NRA).

• Microbiological environmental monitoring.

• Calibration of instruments and glassware's.

• Validation of analytical methods.

• Reference sample collection, preservation and destruction.

• In House Reference standard preparation and standardization

• QC testing in laboratory animals.

• Stability study of vaccines.

• Collaboration with national and International organizations such as WHO, JICA etc.

Mission

“QCL MISSION IS TO RELEASE THE SAFE & QUALITY VACCINES”

 Set up of Division/Section

Performance & Achievements

QC testing of the Products like;

• Tetanus Toxoid (Bulk & Final)

• Allergy Vaccine

• TAB & TC vaccine

• Rabies Vaccine (Bulk & Final)

• Measles vaccine (Basic, Bulk & Final)

• Anti Rabies Serum

• Anti Snake Venom Serum

• Oral Rehydration Salt (ORS)

• Water For Injection (WFI)

• Raw material (Chemicals)

• Raw material (Packaging Material)

• GLP – compliant equipments.

• Well defined Quality Systems with adequate controls.

• Independent Quality Control laboratory to perform physical, chemical and microbiological testing, fully equipped with sophisticated instruments like :

• Biohazard Safety Cabinet

• CO2 Incubator

• Karl Fisher Instrument

• UV-Visible Spectrophotometer

• Water Distillation Plant

• Astell Horizontal Autoclave

• Inverted Microscope

• Cell Bank

• Pyrogen Testing System

• TOC Analyzer

• Flame Photometer

• In order to improve the technical capabilities of QCL project is going on with JICA collaboration; under this project 04 technical experts have been trained in various areas of QC testing.

Programmes & projects

1. QCL is working under the following Programmes and Projects in collaborating with WHO and JICA;

1.      EPI POLIO CONTROL PROJECT WITH JICA COLLABORATION

2.      JPRM “Vaccine & Sera Production. QA & QC” Through World Health Organization (WHO)

Collaboration with other Institutions/Organizations

1.  Japan International Cooperation Agency (JICA)

2. World Health Organization (WHO)

Future Plan

• QCL has following future plans;

1. In Vitro Testing of Rabies vaccine and Sera

2. Real Time & Accelerated Stability of Tetanus, Rabies and Measles vaccine

3. Seroconversion Study of Measles and Rabies

4. Up gradating of Animal Testing facility for QCL