Analysis and Quality Control Plant :
To insure a high level of quality, SHIFAhas invested in laboratories which are equipped with the latest equipment operated by qualified personal who insure very high level of accuracy in the following area:
- Inspecting raw and packing materials.
- Inspecting the product during manufacturing processes.
- Inspecting the quality of the finished products.
- Stability test lab.
Any internationally recognized awards of certifications of excellence of compliance with international standards,
Ex. ISO 9001:2008
- ISO 9001:2008 under certification Number SY09/2066 dated 03December 2009 until 03 December 2012.
- ISO 14001:2004 under certification Number CH10/2091 dated 07 October 2010 until 31 March 2013.
- (G.M.P.)issued by Syrian Ministry of Health under certification number D/1752 dated 01:11:2004.
- any other useful information about the company , its manufacturing plants and its products
2- Quality Assurance:
The sum of the organized arrangements made with the object of ensuring that all pharmaceutical products are of the quality required for their intended use and that quality systems are maintained.
Quality Assurance (QA) department is the main office of quality management which is responsible of monitoring and inspection all processes in the factory departments, which ensure achieving the quality policy's target, subsequently attainment the pharmaceutical form which achieves major three quality standards:
The efficacy: That the pharmaceutical form contains quantity of the active pharmaceutical ingredient (API) as described the external pack, as the same as the dosage, with keeping this efficacy during the shelf life of the product.
The purity: That the product is free from any cross contamination or impurities which may affect on the efficacy of the product, unless those (impurities) which are determined in the pharmacopoeia and with the allowed limits.
The safety :That the product always stays within the safety limits when it used by the patient.
The major duties of QA-department are as the following:
1) Inspectionand monitoring in all production departments,
2) Inspection and monitoring in the laboratories,
3) Inspection and monitoring in the warehouses,
4) Inspection and monitoring in the public utilities, in addition
5) Evaluation the suppliers,
6) Handling customers complaints,
7) Performing self inspection processes,
8) Training and qualifying the employees and the technical staff, and
9) Recall products from the market.
Purpose of Validation
The purpose of this document is to:
- Identify which environments, rooms, equipment and utilities will bevalidated
- Describe the methodology which will be followed
- Describe how the study will be progressed and controlled
- Identify the principal members of the validation team and their responsibilities
- Identify the programme of activities for the study
By signing this document, the Approvers of this document are delegating the authority to the Validation Steering Committee to execute the work as described, recognising that in a project of this complexity and time-scale it may be necessary to modify the Validation Steering committee membership and activities as the project progresses. This document describes the authority which the Validation Steering Committee will have to modify and develop this plan, co-opt members to the group, form a Validation Team and delegate authority to members of that team to perform specific activities.
SHIFA Pharmaceutical Industries have a facility that is contain from two old building and three new building. The facility is already operating to produce tablets, capsules, suppositories, ointment, creams, syrups, vials and ampoules. Also they are expanding in the feature to produce more pharmaceutical forms such as liquid vials, eye drops, aerosols and large parenteral dosage forms (serums).
The immediate need is to validate the facility of the building and the new equipment.
The principles of Good Manufacturing Practice (hereafter referred to as GMP) as defined in the US Code of Federal Regulations and European Community/PIC Guide to GMP as referenced in Section 8 will be applied as appropriate.
The principles of GMP and the detailed guidelines are applicable to all operations which require authorisation. They are also relevant for all other large scale pharmaceutical manufacturing processes. Consequently, there is a requirement to validate the facility and the equipment in it as part of compliance with GMP. The validation activities will largely be concerned with determining that the facility with its utilities and process equipment can be operated repeatedly and reliably according to agreed specifications and in accordance with GMP principles.