Quality System Establishment and Documentation

Establishing a quality system and documentation


Avijeh Sanat Certification Company is able to assist pharmaceutical companies in writing and updating the following documents in accordance with the latest standards such as EU GMP, ICH, PICS, WHO and the Food and Drug Administration regulations, etc:


Documents related to quality policies including SMF, VMP, Quality Manual

Standard operating procedures (SOP) for working with various devices at the production site and laboratory

PQR and PMQC instructions

Standard operating procedures (SOP) for the technical and engineering unit including: Standard operating procedures for preventive maintenance (PM) of devices and preparation of the annual PM plan, EM failure repair request forms, device calibration along with preparation of a schedule for proper monitoring for calibration operations, how to wash and disinfect the water system, how to degrease and replace filters, etc.

Instructions related to the administrative and human resources unit, preparation of personnel job descriptions, etc.

Instructions related to the planning and warehouse unit: preparation of standard batch sheets, control checklists in the warehouse, issuance of goods orders, etc.

General quality assurance instructions including: instructions for handling deviations, instructions for responding to customer complaints, instructions for controlling changes, instructions for quality risk management, instructions for corrective and preventive action, etc.

Preparation of batch records for products in various pharmaceutical forms (tablets, capsules, syrups, ampoules, etc.)

Appropriate labeling system