Quality

Overview:

Our quality initiatives cover all aspects of quality including production, operations, environmental protection and service to customers. We focus on quality in every single area from safety at the work place to the safe delivery of our products to our customers. Our facilities are regularly audited by the most prominent Multinational & National pharmaceutical companies in Pakistan and we fully comply with all their requirements.

These claims can be validated by the fact that Pharmagen Limited is a globally approved and qualified supplier of APIs to GLAXO SMITH KALINE (GSK). In addition to this we supply APIs to other multinationals such as Pfizer/Wyeth, Novartis etc. Our National Customer Profile includes pharmaceutical companies such as SAMI, GETZ, BOSCH, HILTON, CCL and BARRET HODGSON. In a short period of time, Pharmagen Limited has been able to retain the loyalty of its customers due to the consistent quality of its products and services.

Quality Policy

Our Corporate Quality policy is:
"We all are committed for continual improvement in the competitiveness of our products (APIs), services and quality management system for better satisfaction of our customers and stakeholders. We ensure compliance to regulatory requirements, follow industry current good manufacturing practices and achieve our business goals through quality objectives. We are responsible for employee's development for their effective involvement to promote quality culture in the organization."

Quality Infrastructure:

The Quality unit at Pharmagen consists of Quality Assurance and Quality Control; both independent departments.

1. Quality Assurance:

Our Quality Assurance department covers a wide range of concepts, i.e. batch release, validation, qualification, calibration, complaint handling, change control process and deviation. By focusing on all matters both individually and collectively we ensure the highest levels of quality. Quality Assurance therefore incorporates a combination of Good Manufacturing Practices along with multiple initiatives/systems aimed at consistent Quality Improvement in all our areas of functionality.

The major features of the QUALITY ASSURANCE DEPARTMENT include:

  • API products are designed and developed in a way that take account of the requirements of GMP. Raw materials and vendors are regularly audited and qualified.
  • Production and Control operations are clearly specified. Our route of synthesis is validated as per GMP.
  • Our Managers are highly qualified and experienced with specified roles.
  • Consistent evaluation and up-gradation of processes/ systems SOP’s aimed at the optimum operational efficiency and continuous improvement in Quality parameters.
  • All necessary controls on intermediate products are carried out through in process testing.
  • API products are not sold or supplied until key managers release and certify that each production batch has been produced and controlled in accordance with the requirements of the pharmacopoieal regulations (BP,USP,EP) & ICH Guidelines)
  • Satisfactory arrangements exist at site to ensure that the API products are stored as per required temperature and humidity condition and subsequently handled so that quality is maintained throughout their shelf life.

2. Quality Control:

Our quality control unit is comprised of a Chemical lab, Microbiological lab, Stability lab and an in Process lab.

At Pharmagen Limited our quality control department is well equipped with each and every instrument required for the testing of finished products, raw material and packing materials as per pharmacopeia requirements and Current Good Laboratory Practices (CGLP).

  • The Pharmagen laboratory is well equipped with Gradient HPLC systems, GAS CHROMATOGRAPH, UV, FTIR, PARTICLE SIZE ANALYZER, DIFFERNTIAL SCANNING CALORIMETER, COD ANALYZER, AUTOCLAVE, and KARL FISHER TITRATOR etc. required for the testing of our finished products i.e. Penicillins, Cephalosporins and General antibiotics.
  • All testing is carried out according to well defined standard operating procedures (SOPs).
  • Validated Procedures are “in place and in use” for the testing and monitoring of all raw materials, products with in process checks, implemented meticulously.
  • Specifications of all raw materials used in processes are well defined, against set testing protocols.
  • Quality Control testing of each batch of APIs derivatives comply with the latest requirements of BP and USP Pharmacopoeias.
  • Stability studies are conducted for each product before starting its commercial production. Sample batches from normal production are subjected to stability studies as per well-defined procedures.
  • Our Quality Control Managers and Analysts are highly qualified and experienced with clearly specified roles.

Certifications

Pharmagen Limited has the following certifications:

  • Quality Management System (QMS) ISO 9001:2015
  • Environmental Management System (EMS) ISO 14001:2015
  • GMP Cetification by Drug Regulatory Authority, Government of Pakistan. (DRAP).
  • General Requirement for Competence of Testing and Calibration Laboratories ISO/IEC 17025:2017
  • Occupational Health & Safety Management Systems ISO 45001:2018