Quality

Analysis and Quality Control Scheme:

Equipment operated by scientifically qualified personnel ensures a very high level of accuracy in the following areas:
- Verification and inspection of raw materials and packaging materials.
- Verification and inspection of preparations during manufacturing processes.
- Verification and inspection of the quality of final preparations.
- Preparation of stability studies and laboratory tests to ensure product stability.

Internationally recognized certifications for international standards granted to Chemi:

- ISO 9001:2015
- ISO 14001:2015
- ISO 45001:2018
- (G.M.P.) issued by the Syrian Ministry of Health

Equipment operated by scientifically qualified personnel ensures a very high level of accuracy in the following areas:

- Verification and inspection of raw materials and packaging materials.
- Verification and inspection of preparations during manufacturing processes.
- Verification and inspection of the quality of final preparations.
- Preparation of stability studies and laboratory tests to ensure product stability.

Internationally recognized certifications for international standards granted to Chemi:

- ISO 9001:2015
- ISO 14001:2015
- ISO 45001:2018
- (G.M.P.) issued by the Syrian Ministry of Health

     

 

Quality Assurance:

All equipment, processes, and organized arrangements are in place to ensure that all pharmaceutical products are of the high quality required for their intended use, and to ensure quality assurance systems are in place.
The Quality Assurance (QA) Department is the main department and office of quality management, responsible for monitoring, inspecting, and verifying all processes across the factory. This ensures the achievement of the quality policy objectives, which meet three key quality standards:
Efficacy: The pharmaceutical form contains the exact quantity of active pharmaceutical ingredients (APIs) indicated on the outer package, at the same dosage, and maintains this efficacy throughout the product's shelf life.
Purity: The product is free from any contamination or impurities that could affect its efficacy, unless these impurities are identified in the drug and within the permissible limits.
Safety: The product must always remain within the safety limits when used by the patient.
The main responsibilities of the QA department are as follows:
1) Inspection and verification monitoring in all production departments,
2) Inspection and verification in laboratories,
3) Inspection and verification in warehouses,
4) Inspection and verification in public facilities,
5) Supplier evaluation,
6) Handling customer complaints,
7) Conducting self-inspections,
8) Training and qualification of employees and technical personnel,
9) Processing returned products.

Verification:

Purpose of verification:
- Identify the correct environments, departments, equipment, and facilities that comply with the international standard
- Describe the methodology to be followed
- Describe how the studies and control methods will be presented
- Identify the members of the main verification and inspection team and define their responsibilities

 

Background to the verification:

Kimy Pharmaceutical Industries is an integrated industrial facility in terms of service infrastructure and scientific laboratory equipment for the pharmaceutical industry. It is equipped with the following production departments:
Tablet and coated tablet production line, syrup and suspension production line, oral drops production line, external solutions production line, ointment and cream production line, various types of eye drops production line, capsule production line, suppository production line, ampoule production line, liquid vial production line, serum production line, and nutritional supplement line.
The principles of Good Manufacturing Practices (hereinafter referred to as GMP) are also applied, along with detailed and applicable guidelines for all required operations.