Quality

Quality Control

Hi Pharm Quality Control Laboratory has all the necessary critical instruments. The entire instruments are qualified for installation, operation, and performance qualification. Instruments are periodically calibrated by an accredited third party.

– Our Goal in Hi-Pharm is to manufacture & deliver consistently zero-defect products to the patients.

– In Hi Pharm, the quality, efficacy, and safety attributes of products must be ensured as we believe in “doing things right the first time”.

In Hi pharma, Quality control is believed as one of the most vital departments. It acts as a barrier between manufacturing unit and market to ensure the quality of all batches manufactured, at every stage of manufacturing, processing of drug products.

The objective of the QC department is achieved by performing the following areas:

Coordination with:

Manufacturing department in controlling of their process and products at every stage of manufacturing to meet the pre-established specifications through testing, auditing, and reporting.
Quality assurance department and with R&D for development of specifications and analytical procedure.
Technical audits of the QC laboratories to determine the analytical quality systems for yielding the highest quality information.
Plan and manage all the activities of the QC department sections (Raw Materials, Water Station Treatment, Finished Products, Stability, and Microbiology)
Review the adequacy and relevance of specifications and analytical procedures in coordination with the Quality assurance department and with R&D.

2. Ensuring the functioning of analytical instruments and equipment.

Sampling, inspection, and testing of:

Raw material as per Standard Testing and Preparation and approval or rejection after verifying the observations/results as per specifications and its documentation.

Quality Assurance

At Hi Pharm, Our mission is to provide-secure a better quality of life for the entire family by providing them safe & effective products.
The quality policy is implemented through a comprehensive and maintained QMS to ensure meeting our high expectations of quality for our patients & stakeholders.

Acquired the latest QMS, safety & Environmental systems Certificates (ISO 9001:2015, ISO45001:2018 & ISO14001:2015)

Our belief is that quality is built into the product across the whole product life cycle.

Hi Pharm is one of the best manufacturing facilities of pharmaceutical products in Egypt where manufacturing, storage, distribution, quality control, and testing of approved drugs are carried out in full compliance with local and international GMP guidelines, good storage Practices (cGSP), Good Distribution Practices (cGDP), etc…

Hi Pharm Facilities are designed and operated in accordance with the main GMP principles:

To ensure the quality of the product;
To protect the operators
To protect the environment.

-For manufacturing of hormone products Hi Pharm has separate, dedicated, self-contained facilities. The hormone self-contained area is totally separated and has its separate entrances, staff facilities, and air-handling systems.

Hi Pharm carries out strong risk management under the supervision of top management which covers all business and manufacturing activities.

Hi Pharm has a complete program for validation to fulfill requirements, ensure that all processes and equipment affecting the quality, integrity, safety, and efficacy of the pharmaceutical product are qualified and validated. With the successful conclusion of validation, Hi Pharm proves that all pharmaceutical products produced in the validated plant are unobjectionable, suitable for use, and correspond to the requirements of the product license.

The concept of validation covers the following fields of activity:

Qualification of buildings, utilities, rooms, and AHU systems
Qualification of equipment and service units
Validation of production processes
Validation of cleaning processes
Periodic revalidation within the scope of a change control plan