A quality management system (QMS) is a collection of procedures focused on achieving quality policy and quality objectives to meet customer requirements. It is expressed as the organizational structure, policies, standard operating procedures (SOPSs), processes and resources needed to implement quality management.
In the pharmaceutical world, the QMS is of vital importance to protect the final user (the patient) from receiving a medicinal product which is defective or below its intended quality level.
At Pharmaconsulta, we can design your QMS and create SOPs to best suit your daily working processes, in the manufacturing of medicinal products and food supplements(EU GMP), wholesale and distribution of medicinal products and active pharmaceutical ingredients (APIs), transportation of medicinal products, as per EU GDP guidelines, as well as cultivators of cannabis and herbal products as per EU, WHO and Europam GACP guidelines.
In the face of a challenging regulatory environment, some leading Pharmaceutical companies have found ways to improve quality and costs significantly. To drive this kind of beneficial change, companies must first create a culture where quality objectives are transparent, well understood, and undoubtedly these goals can be achieved by following certain sets of procedures called “Standard Operating Procedures” (SOP). Procedures are essential for any plant’s effectiveness and efficiency, and they are a regulatory requirement in the Pharmaceutical Industry. A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. A Parenteral Drug Association (PDA) survey found that a typical pharmaceutical company must manage an average of 1250 CGMP-required SOPs and that the average maintenance burden is 15,000 h per firm.
A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization. The development and use of SOPs are an integral part of a successful quality system. It provides information to perform a job properly, and consistently in order to achieve predetermined specification and quality end-result.
SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. They may describe, for example, fundamental programmatic actions and technical actions such as analytical processes, and processes for maintaining, calibrating and using equipment. Sops are intended to be specific to the organization or facility whose activities are described and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations.
SOP must contain step by step instructions that employers must refer to in daily work to complete various tasks more reliably and consistently.
SOP’s include the following:
- Purpose – What is the objective of SOP?
- Scope – What are the applicability and use of SOP?
- Responsibility – Who will perform tasks?
- Accountability – Who will ensure implementation of procedure?
- Procedure – How tasks will be performed?
- Procedures are not an end in themselves—they do not guarantee good performance or results. More important are well-designed systems and processes, qualified employees and a motivating company culture. Procedures support process people–environment but do not create processes, qualified people, or a good working environment.
- To provide people with all the safety, health, environmental and operational information necessary to perform a job properly. Placing value only on production while ignoring safety, health and environment is costly in the long run. It is better to train employees in all aspects of doing a job than to face accidents, fines and litigation later.
- To ensure that production operations are performed consistently to maintain quality control of processes and products. Consumers, from individuals to companies, want products of consistent quality and specifications. SOPs specify job steps that help standardize products and therefore quality.
- To ensure that processes continue uninterrupted and are completed on a prescribed schedule. By following SOPs, you help ensure against process shut-downs caused by equipment failure or other facility damage.
- To ensure that no failures occur in manufacturing and other processes that would harm anyone in the surrounding community. Following health and environmental steps in SOPs ensures against spills and emissions that threaten plant neighbors and create community outrage.
- To ensure that approved procedures are followed in compliance with company and government regulations. Well-written SOPs help ensure that government regulations are satisfied. They also demonstrate a company’s good-faith intention to operate properly. Failure to write and use good SOPs only signals government regulators that your company is not serious about compliance.
- To serve as a training document for teaching users about the process for which the SOP was written. Thorough SOPs can be used as the basis for providing standardized training for employees who are new to a particular job and for those who need retraining.
- To serve as a checklist for co-workers who observe job performance to reinforce proper performance. The process of actively caring about fellow workers involves one worker coaching another in all aspects of proper job performance. When the proper procedures are outlined in a good SOP, any co-worker can coach another to help improve work skills.
- To serve as a checklist for auditors. Auditing job performance is a process similar to observation mentioned in the previous item only it usually involves record keeping. SOPs should serve as a strong basis when detailed audit checklists are developed.
- To serve as an historical record of the how, why and when of steps in an existing process so there is a factual basis for revising those steps when a process or equipment are changed. As people move from job to job within and between companies, unwritten knowledge and skills disappear from the workplace. Properly maintained written SOPs can chronicle the best knowledge that can serve new workers when older ones move on.
- To serve as an explanation of steps in a process so they can be reviewed in accident investigations. Although accidents are unfortunate, view them as opportunities to learn how to improve conditions. A good SOP gives you a basis from which to begin investigating accidents.