|The Arab Company for Gelatin and Pharmaceutical Products has major responsibility to the society to satisfy the customer by providing safe, effective, pure and reliable, pharmaceutical and veterinary product at an affordable price.|
Arab Caps is committed to :1. Complying its quality management system with the requirements of the international standard (ISO 9001:2015)
2. cGMP (current good manufacturing practices) requirements
3. Egyptian Ministry of Health regulations
4. Complying its environmental management system with the requirements of the international standard (ISO 14001:2015) that is focused on sustainable improvement its impact on the environment and, preventing pollution
5. Complying with relevant environmental legislation and regulation, as well as with other requirements to which Arab Caps has submitted.
6. Complying its occupational health and safety management system with the requirements of the international standard (OHSAS 18001:2007)
Our strategy to achieve our target is to :1. Conducting an on-going training programs to prepare qualified staff members where everyone is responsible for the quality within the company and for maintaining high performance standards
2. Minimize waste by evaluating operations, measuring its impact on the environment and ensuring they are as efficient as possible and set targets for ongoing improvements.
3. Eliminate and minimize risk to employees and interested parties who may be exposed to OH&S risks concerned associated with its activities.
4. Reviewing of quality management system, Environmental and OHSAS system every year, including reviewing of policy, objectives and impacts to ensure system implementation suitability and effectiveness.
5. We build customer satisfaction through team work and continual improvement for our staff competence.
6. Continual improvement with respect to ISO 9001:2015 and ISO 14001:2015 standards.
7. We establish, maintain and review our quality objectives that are consistent with this policy.
Arab Caps Company recognizes its responsibility to develop, manufacture and provide
high quality pharmaceutical products which are safe, effective, stable and fully
meet regulatory requirements and customer needs.
Quality assurance is responsible for the entire activity related to monitoring
and control of manufacturing and analysis of products manufactured at Arab Caps
Company and the products analyzed on contract manufacturing. Quality Assurance (QA)
system monitors and controls various procedures including return goods , repackaging
, final product release ,rejection, documentation, change control, qualifications,
validations, batch record review, investigations , handling of recalls and complaints
, training , quality management system ISO 9001:2015 , ISO 14001:2015 , OHSAS 18001:2007
Arab Caps Company conducts self assessment through self inspection program. A
schedule for self inspection for all departments in the factory is prepared and
maintained on annual basis. The internal audit is conducted for each department
minimum once a year. The self inspection covers the cGMP, ISO, WHO, EU requirements.
Audits are also conducted as per schedule / production plan for the suppliers and
the toll manufacturing companies. A written procedure for internal and external
audits is followed and all records related to the audit are maintained with quality
assurance department at Arab Caps Company.
All the suppliers for starting active, inactive and packaging material are evaluated
according to quality parameters, price suitability, and delivery rate. The suppliers
of critical starting and packaging materials, active pharmaceutical ingredient and
excipients , containers, closures and printed packaging materials are assessed as
per the written approved procedures as follow:
1. The samples received are evaluated and analyzed for intended quality. An audit questionnaire is sent to the supplier to ensure that adequate process controls are in place and cGMP requirements are in compliance. If needed the supplier facility is audited.
2. The performance of the suppliers is evaluated according to consistency of supplied
lots conforming to their respective specifications of the material
Release of finished products is done by Quality Assurance department through reviewing
the processing and packaging records, in process quality control records, bulk and
finished product reports to ensure compliance at every stage of processing and packaging
to approved procedures and specifications.