Manufacturing/Production Process

 

The state of art production department is equipped with the latest technology and machinery. Continually, Alpha pharma invests in development of methods for manufacturing quality products.

AP production department contains two types of dosage forms, oral solid dosage form, and liquid dosage form. AP Production team is manned by highly skilled, qualified and professional staff. These areas are set with sophisticated and automated equipment, to manufacture varieties of products.

The well-designed capacity of the production area was set to fulfill the market demands, and to produce high quality products that satisfy safety and efficacy requirements.

Alpha pharma production department is a Good manufacturing practices area (GMP) certified by SFDA, to meet international standards in terms of drugs manufacturing.

 

Quality Process

 

Alpha Pharma Quality Management System is focused on achieving quality policy objectives, to meet the regulatory and customer requirements. The strong base, and presence of Quality management system is important for the satisfaction of regulators and stakeholder.

Quality Assurance in Alpha Pharma ensures that quality systems are In-place, In-use, maintained, and continuously improved. Line inspection provides assurance that the manufactured products follow the pre-determined in-process specifications, and comply with its standards. The environmental conditions are being qualified and monitored. The water system and utilities are qualified to assure compliance with the regulations and standards.

Quality Control activities cover all measures from sampling, testing and analytical method, to ensure that raw materials, intermediates, packaging materials and finished products comply with established specifications for identity, strength, purity and other characteristics.

The stability program has comprehensive storage and testing capabilities, with detailed compliance strategies that are fully compliant with ICH guidelines. The storage chambers are continuously monitored, and operate independently, with its own temperature and humidity controls.

The advanced microbiological testing facility is in line with international standards, and provides a wide range of support for, ensuring the compliance of our products and facility. Quality Control employs well trained staff and state-of-the-art equipment.

Validation is an integral part of the quality system, that it provides documented evidence, with a high degree of assurance that a process, method or system, will consistently produce to the required specification, in accordance with accepted standards of cGMP, and local or international regulations.

Quality improvements are being accounted by undertaking compliance program, that assures strict adherence to the policies and principles of Integrated Quality Management System based on ISO 9001:2015, ICH Q10 pharmaceutical quality system coupled with ICH Q8 Pharmaceutical Development and ICH Q9 Risk Management.

Striving for excellence through continuous improvement is the way of life in Alpha Pharma

Alpha Pharma has been awarded with the following certification:

  1. Saudi FDA Manufacturer GMP Compliance
  2. ISO 9001 Quality Management System
  3. ISO 14001 Environmental Management System
  4. ISO 45001 Occupational Health and Safety Management System