In order to ensure the pharmaceutical products for their intended use, and to meet requirements of marketing authorization and pharmaceutical safety, efficacy and quality, the top management of this company establishes Quality Policy according to our company Quality Manual and all staff must follow this policy. The Quality Policy is
"We begin everything with quality, ensure quality in every process to obtain excellent outputs that meet regulatory requirements and customer satisfaction".
In pursuit of our quality policy the company has established a quality management system in accordance with the requirements of GMP. The quality management system is implemented and maintained as specified in the company's standard operating procedures (SOPs). The effectiveness of the quality management system is continuously improved through self inspections/internal quality audits, regular management reviews and as a result of corrective and preventive actions.
The processes needed to effectively carry out the activities of the company are identified to ensure ongoing customer satisfaction. Management ensures that the resources and the information needed to carry out these processes are made available. These processes are monitored and prescribed measurements are carried out.
All new employees engaged in sections of the company whose activity has a bearing on product quality are taken through a basic training on GMP.
The documentation of activities affecting product quality is based on a consistent set of documents that include:
•Documented standard operating procedures (SOPs) and associated forms
•Technical production documents
•Other documents required for GMP compliance and required to meet statutory requirements
Quality control activities including sampling, testing, required documentation and records, and release procedures are established to ensure that the necessary and relevant tests are actually carried out and that materials are not released for use. No products released for sale or supply, until their quality has been judged to be satisfactory.
Products are tested at various stages as specified in the quality plans. Test specifications specify the acceptance criteria.
The monitoring activities also include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures if any.
No batch of product is released for sale or supply unless certified by the authorized person(s) that all the requirements are met and that it is in accordance with the requirements of the marketing authorization.