QUALITY SYSTEM PROCEDURES

Quality > Summary of QUALITY SYSTEM PROCEDURES

> Documents & data control

> Quality system review and internal audit and corrective action

> Receipt & progressing OG order

> Production planning & programming

> Purchasing

> Manufacturing control

> Quality control (Chemical lab.)

> Quality control (Microbiology lab.)

> Quality control (Microbiology lab.)

> Quality assurance

> Raw material store

> Finished goods store

> Packaging store

> Maintenance

> Training

> Products complaints & corrective actions

> Recalls

> Cleaning department

> Water treatment plants

> Product identifications & traceability

> Inspection, measuring & test equipment

> Preventive & corrective actions

DOCUMENTS & DATA CONTROL

This procedure defines controls for the issuing and updating of all documents forming part of the quality system. These include the Quality Manual, Quality System Procedure, Instructions and Forms. The purpose of this procedure is to ensure that the lasted amendments and copies of pertinent documents are available to all personnel at all times. The Management Representative is responsible for reviewing and approving all procedures and their amendments and for ensuring that documents are in accordance with the requirements of ISO 9002: 1994. The procedure also describes the format for documenting procedures and for identifying all documents in terms of numbers and issue status.

QUALITY SYSTEM REVIEW AND INTERNAL AUDIT AND CORRECTIVE ACTION

It is important that the quality system procedures established at ALEPPO PHARMACEUTICAL IND. (ALPHA) remain effective and comply with the standards. Therefore periodic and systematic reviews of the system and auditing of procedures shall take place. The reviews are conducted by Management who examine the results of audits, inspection and test performance, customer feedback complaints and any other information that can assist in identifying system weaknesses and areas for improvement. The planning and conduct of audits are defined and these ensure that procedures are being followed, that personnel understand procedures and that problems are identified and corrected. The results of reviews and audits are documented and the Management Representative is responsible for co-ordination of all corrective and for ensuring that these are fully implemented and effective.

RECEIPT & PROGRESSING OF ORDER

This procedure defines the method of receiving customer's requirements, and the execution of these orders in an efficient manner, until its delivery in a safe and good conditions.

PRODUCTION PLANNING & PROGRAMMING

The aim of this procedure is to make sure that the production requirements are well defined and precisely organized as it is needed in the store at the right time to cause no production delays. *Any special orders for export are well planned & executed to meet the agreed upon delivery date.

PURCHASING

This procedure sets out the requirements for ensuring that materials purchased will consistently meet the quality standards set by ALPHA. This is achieved by defining the process and criteria for raising purchase orders and the control of supplies.

Orders are raised on the Purchase Requested form and are made sufficient to fully define the material, quantity and quality requirements. Orders are placed with suppliers of proven performance for which performance records are maintained.

Formal communicated is maintained between purchasing and Quality Control regarding supplier performance. Finally the signature of a Director is required to authorize any expenditure.

MANUFACTURING CONTROL

This procedure organizes the works at the various production Departments, where the approved raw material is transferred to pharmaceutical form in conformity with international rules of good manufacturing procedure (GMP).

This means that quality control is applied on the various stages of the manufacturing of any one product, and cannot proceed from one stage to the next, unless authorized by Quality Control.

This will ensure the discovery of any deviation in an early stage before passing to the next one.

Quality Assurance & Quality Control efforts are combined to lead to high quality product continuously.

QUALITY CONTROL (CHEMICAL LAB.)

QUALITY CONTROL (MICROBIOLOGY LAB.)

QUALITY CONTROL (MICROBIOLOGY LAB.)

All quality control labs. are equipped with the latest and most advanced instruments enabling themto carry-out all required tests and analysis to obtain the highest quality products.

High qualified personnel are employed to ensure the good performance of the said labs., and to carry-on the continuous training of chemists working in the labs.

The latest editions of USP - B.P - IP - MARTIN DALE - Merck index and GMP, references are used to apply the latest rules of good manufacturing practice.

Stability program is adopted to ensure that the potency of all products is within the accepted limit during the shelf life of the product.

QUALITY ASSURANCE

The aim of the procedure is to obtain continuously high quality products that conform to specification set by the international standards of pharmaceutical industries.

The main task is to make sure that everything is being done according to GMP rules, starting from the raw material, packaging material, Q.C. labs. to the final packaging & storage.

Quality assurance manager reports directly to the management in order to avoid any influence exercised by manufacturing department or Q.C. labs. This ensures that their decisions are taken independently.

RAW MATERIAL STORE

This procedure define that details of receiving the raw material from the approved supplier, storing it in the allocated areas (quarantine) until checked and approved by Q.C.; then transferred to the right storage area.

Storage conditions are well specified and accordingly.

Any rejected materials by Q.C. is quarantined and returned to supplier or destroyed.

FINISHED GOODS STORE

The aim of this procedure is to receive the finished products manufactured by ALPHA and store it in the relative stores according to specified storing conditions.

Shipping of finished goods is maintained according to first-in first-out principle.

PACKAGING STORE

This procedure defines the details of receiving the packaging materials from the approved suppliers, storing it in the allocated areas (quarantine) until checked and approved by Q.C.; then transferred to the right storage area.

Storage conditions are well specified and accordingly.

Any rejected materials by Q.C. is quarantined and returned to supplier or destroyed.

MAINTENANCE

This procedure defines the action to be taken to maintain the running of production machinery in its optimum capacity, and to determine the requirements of need spare continuously.

Also it guarantees the continuous supply of power from generators as well as of the steam, compressed air, gas...etc.

It determines also the implementation of a program for periodic & preventive maintenance of equipment & machinery.

TRAINING

This describes the applied steps to train all new employees and according to their training needs.

It also describes the measures to upgrade the level of old employees by a continuous training program supervised by the production manager according to GMP. Rules.

It also describes the maintaining, keeping and filing the training records.

PRODUCTS COMPLAINTS & CORRECTIVE ACTIONS

This procedure describes the ways to collect the complaints and comments regarding the finished products, from every possible different areas of the market.

Each received complaint will result in an issue of product complain file, where a full investigation is launched, finalized, and raised to the management to take a final decision and a corrective action whenever required and to make sure that it will not re-occur in the future and to upgrade continuously the quality of products.

RECALLS

This procedure defines the quickest and most effective steps to be taken to recall any certain batch of product due to in conformity of specification, if occurred.

A system is applied to facilitate the identification of final destination of every batch of finished product, thus making it easy to track its whereabouts.

CLEANING DEPARTMENT

The aim of this procedure is to detail the various cleaning programs applied to different areas of the factory i.e. (production areas - service slabs -roofs & yards).

All garbage is systematically collected from various areas and duly burned daily in an incinerator.

WATER TREATMENT PLANTS

This procedure defines the required steps and control to be applied for the well supply of various grades of water required by production, in order to meet specification set by GMP i.e. soft water, D.M. water and distilled water.

PRODUCT IDENTIFICATIONS & TRACEABILITY

This procedure describes the system applied for numbering the various batches manufactured, and to show its manufacturing & expiry date.

It also defines the instructions submitted to the finished goods store to show the batch number of any product, on all shipping documents shipped any where in order to facilitate tracking or recall, if required.

It describes the numbering system to be followed to assign code numbers to all incoming raw materials to facilitate the tracking through all operations, starting from identifying, weighing, mixing...etc. till the completion of finished product.

INSPECTION, MEASURING & TEST EQUIPMENT

Inspection, measuring & test equipment used in production or Q.C. labs. are a major factor in defining the quality of the product.

Therefore a specific schedule is adopted to keep all these equipment calibrated periodically, according to manufacturer instructions. -Some of lab. equipment are home calibrated, as required; while the rest of the equipment are calibrated by the traceable and officially approved local authority.

Calibration certificates are acquired for the required equipment, and kept on file; an identification card is provided for every piece of equipment, (showing its name, serial no., sensitivity, last calibration date and the next calibration date), posted on the wall right above the equipment.

A written record of calibration is also well maintained & filed for all equipment.

PREVENTIVE & CORRECTIVE ACTION

The aim of this procedure is to define the ways & means followed to avoid and correct problems when occurred.

Internal auditing reports, customers complaints, inspection reports, in process inspection reports or any records are analyzed, where results are extracted, compiled in form of any report by the management representative, and discussed at the periodic management meeting.

The preventive measures are suggested in the meeting approved and followed up for actual implementation with the related personnel.

ISO-9002 CROSS REFERENCE