CHI PHARMACEUTICAL LIMITED
CHI Pharmaceuticals Ltd is a part of TGI group which currently operates in nine countries in Africa. The site was commissioned in 1990 for marketing and distribution of imported finished pharmaceutical products. The company now manufactures and markets its own range of pharmaceutical product lines consisting of tablet and capsule dosage forms. The factory is located in an industrial area of Ajao Estate, Oshodi in Lagos state of Nigeria. The company has adequate buildings and facilities in place. The company stated that the factory has an installed annual capacity of 360 Million tablets and 190 Million capsules with a provision for 30-50% expansion. The factory building consists of three floors covering a total land mass of 5500 square meters as follows:
1). Ground floor – made up of material warehouse, production, laboratory and canteen,
2). First floor – Mezzanine (utilities and services)
3). Second floor – Administrative Offices.
History of WHO and/or regulatory agency inspections. There had been series of WHO advisory/ gap analysis inspections on the site. The last WHO pre- inspection was carried out between the 18th and 19th of April, 2013 which resulted in deficiencies put on notification to the company. The company has since developed and submitted a CAPA in response.
The factory site has been duly inspected, approved and issued with marketing authorization and GMP certificates by NAFDAC for its various dosage formulations which include oral solids and capsules prior to commencement of WHO visits.
Focus of the inspection The inspection focused on the review and verification of the company’s CAPA following the last audit conducted, as well as manufacturing and control procedures of OSDs in the facility with special focus on Zinc Sulphate 20mg dispersible tablet. It covered a review of all the six systems – Quality Management, Facilities and Equipment, Materials, Production, Packaging and labelling, as well as laboratory controls.
Anti-hypertensives, Multivitamins, Health Drinks etc.
Physical address: Plot 14, Chivita Avenue, Ajao Estate, Oshodi, Lagos State
Dr. Steve Onya – Managing Director