SOP's needed in FDA-regulated industries
- Mark McClain, R.Ph., CEO, Big Horn Safety LLC
- Jan 27, 2017
- 6 min read
SOP's are needed in any manufacturing industry. As defined in Mr. Sanjay Jain's article attached below, SOP's or standard operating procedures are required in the good manufacturing practices regulations, 21 CFR parts, 11, 210 and 211 for pharmaceutical manufacturing. Various sections throughout these regulations state similar wording such as "procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed." (Sec. 211.11 (d)). Another example is in the equipment section subpart D which states, "Written procedures shall be established and followed for cleaning and maintenance of equipment.....These procedures shall included, but are not necessarily limited to, the following:" There are other required SOP's in the other subsystems of the Materials, Production, Facilities and Equipment, Packaging and Labeling and Laboratory control systems. They are also required in manufacture of other FDA-regulated products (compounding pharmacies, dietary supplements, medical devices, etc.). The article details what elements and format are needed for any SOP and h
As described in the sections of the article below, SOP's have the following benefits besides requirements to manufacture a quality pharmaceutical product:
"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 pre-determined specification and quality end-result.
2. Need Of SOP
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 employ must refer in daily work to complete various tasks more reliably and consistently. SOP makes clear about followings - ·What is the objective of SOP (Purpose) ·What are applicability and use of SOP (Scope)? ·Who will perform tasks (Responsibility) ·Who will ensure implementation of procedure (Accountability) ·How tasks will be performed (Procedure) 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.
3. Benefits of SOP
1.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.
2.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.
3.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.
4.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.
5.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.
6.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 re-training.
7.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. 8.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.
9.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.
10.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 being investigating accidents."
A compounding pharmacy preparing for an FDA inspection as an outsourcing facility for sterile products asked me if I could write SOPs for them. I declined stating that although I had seen thousands of SOPs in various companies I had inspected, they had to write their own SOPs and by someone that is doing the work and knowledgable with all the operations. I stated that a 3-5 audit would not allow me to be fully knowledgable with their operation enough to write the SOPs involved. I knew from the sterile compounding setting I had worked in had approximately 75 SOPs. To draft this many SOPs for a small operation could take many hours. In comparison, large manufacturing operations can have as many as 600 to 1300 SOPs.
As Mr. Jain states well in his article:
"6. SOP Process
A) SOP Preparation The organization should have a procedure in place for determining what procedures or processes need to be documented. Those SOPs should then be written by individuals knowledgeable with the activity and the organization's internal structure. These individuals are essentially subject-matter experts who actually perform the work or use the process. A team approach can be followed for better results. SOPs should be written by an individual who performs the tasks routinely or someone who is directly responsible for the performance of the task. Ideally, SOP’s should be written by teams that include some or all of the following people:- ·Those who will perform the job ·Those who will perform maintenance on equipment involved in an SOP ·Engineers or others who design equipment and processes ·Technical initiator ·Safety personnel ·Environmental personnel ·Equipment manufacturers ."
Mr.Jain further notes in this article how SOPs are required in the medical device manufacturing industry:
"The Code of Federal Regulations for medical device manufacturers and other related regulated entities (Title 21, CFR Part 820) states repeatedly that firms must “establish and maintain” procedures. To do so, companies should define, document (either on paper or electronically), and implement standard operating procedures (SOPs). Additionally, companies must then follow up, review, and revise these documents as needed.
The intent here is simple: Companies must ensure that their organization develops and manages operationally sound procedures that are compliant with the law. FDA audit findings in 2006 clearly indicate that ensuring establishment and maintenance of procedures is fundamental in FDA’s inspection strategy. During inspections in 2006, the agency commonly observed that companies failed to keep accurate records and that they neglected to establish and maintain procedures.
8. Conclusion:
SOPs serve as a fundamental means of communication for all levels of the organization. Not only do they involve employees departmentally, but they also allow management and employees to gain a cross-functional view of the organization. This approach encourages employees to think about how process change may affect other functional areas. A good system forces Employee to think through processes and examine how Procedure might affect product, personnel, production, and equipment. It shall be noted that the Best written SOPs will fail if they are not followed."
If procedures are not in writing or are there but not being followed, then a company is likely receive an FDA-483 Inspectional Observations form at the end of the inspection by FDA, citing a violation of the specific section of the GMP regulations regarding SOP's. It depends on the section of the GMP regulations that are cited related to SOP's and how serious their impact of not being followed or not having documentation of a process may have on a product's quality and if it could result in adulteration and further violations such as recalls, seizure, detention, consent decree or prosecution.
To see further elements of this article and how an SOP should be formatted, see the full article quoted above by Sanjay kumar Jain titled:
Standard operating procedures (SOP) - Back Bone of Pharmaceutical Industries, 09/17/2008
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