When it comes to the pharmaceutical industry, quality is everything. Apparently, this is because the final product affects every patient’s life and their ability to take part in the society. It helps patients fulfill their aspirations and contribute to humanity.
Maintaining the highest quality is of the utmost importance to our vision and daily routine. Therefore, our instinctive perception is led by the objective of exceeding customer expectations in all quality aspects. Adapting to customer’s growing expectations and the dynamic market conditions is the force of our continuous improvements and excellence. It’s also the motivation of our unstopping aspiration for higher summits.
MAKING QUALITY PERSONAL
Entrusting our employees with decisions involving the quality concept makes it a personal goal for each one in APEX Pharma team. That can be done by providing them with training, development, and recognition that is necessary to excel in their job. Also, urging them to address the quality concept during the communication with our customers to confirm it as one of the main values in our corporate identity.
OUR MANUFCATURING QUALITY
We focus on every step in the pharmaceutical process, from our suppliers to the delivery of our quality products to every patient’s door. Therefore, quality is reflected in every step throughout the product life cycle. Each role and responsibility is authenticated by systematic and process-centered approaches. Also, process coordination, including production, storage, distribution, and delivery, is guaranteed through real-time alliance and communication.
ACCREDITATION & CERTIFICATES
APEX Pharma is awarded certifications for Good Manufacturing Practices (GMP) compliance from the Egyptian Ministry of Health (MOH), Saudi Food and Drug Authority (SFDA), and Quality Management System from ISO QMS 9001:2015, EMS 14001:2015, OHSMS 45001:2018, Lab accreditation 17025:2017.
ISO 9001:2015 (Quality Management System)
Specifies the requirements for the consistency of the provided products that meet the customer’s needs and assures conformity to the applicable statutory and regulatory requirements.
ISO 14001:2015 (Environmental Management System)
Ensures and helps the organization to achieve the intended requirements and outcomes of its environmental management system, which provides value to the organization itself and the interested parties.
OHSMS 45001:2018 (Occupational Health & Safety Management System)
Confirms compliance with the requirements of the occupational health and safety management system, preventing work-related injury and ill-health to support the protection of the employees.
ISO/IEC 17025:2017 (General Requirements for the Competence of Testing & Calibration Laboratories)
Adapts our laboratories to the competence, impartiality, and consistent operation of laboratories. This ensures that quality control tests are performed under the highest standard operating procedures.
Certificate of GMP Compliance of a Manufacturer from the Saudi FDA
Summing the total of the organized arrangements made to ensure that medicinal products are of the quality required for the customer intended use and that they apply to all life cycle stages of the production processes.
APEX Pharma is keen to obtain certifications by international authorities, such as the European Medicines Agency (EMEA).
Stability Performance Excellence Certificate (SPEC)
On the 5th of August 2021, Apex Pharma has obtained the Stability Performance Excellence Certificate (SPEC) from the Egyptian Drug Authority.