How to create a winning Standard Operating Procedure - often referred to as Standard Operating Practices (SOP's). These are used to ensure that production processes are consistently and repeatedly executed exactly in accordance with a proven methodology. SOP’s must be available for every task that is used in the manufacture or testing of a regulated product.
A Standard Operating Procedure template is a written step-by-step procedure that quality control (QC), quality assurance (QA), and production units use in order to assure that the accuracy and precision of the original product development is maintained in the transformation from small trial and batch work to full scale production of the product. SOP's are an essential part of the consistent replication of the tasks that are used to produce a regulated product to a pre-approved quality specification.
SOP's are active documents that are routinely reviewed and amended as production processes are repaired, altered or replaced. Having defined all the appropriate standard operating procedure template and practices they are then used as audit standards to ensure that these define methods are being meticulously followed and adhered to.
The use of the How to create a winning Standard Operating Procedure format forms the backbone of regulatory compliance activities in all companies regulated by Good Manufacturing Practice (GMP) rules and regulations.
Having described the use and importance ascribed to Standard Operating Procedure template it is incongruous to now inform you that the number one failure in compliance is; “not following written instructions”. This is closely followed by the number two failure: “no documented instructions available”.
It is hard for any validation professional to understand the mentality of persons that would patiently wait for a regulatory visitation – knowing it was routine for their operators and laboratory technicians to execute tasks without using a documented standard operating procedure template.
It therefore becomes pretty obvious and very essential for personnel to be trained in the use of documented standard operating pratice, in the execution of their daily tasks, to ensure they are aware of why and how these SOPs play such an important role in fulfilling the specific company’s regulatory requirements from WHO, FDA, EMEA or other national health authorities. Health authorities world-wide expect pharmaceutical, cosmetic and food producers to use approved manufacturing processes in written SOPs format.
Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established standard operating procedure template to ensure that the quality system satisfies the requirements of Part 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c). Specifically, there is no evidence that management reviews have been conducted.
Failure to establish procedure for, and to conduct, quality audits to assure that your firm's quality system is in compliance with the established quality system requirements, and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Specifically, there is no evidence that you have established quality audit standard operating procedure template or that quality audits have been performed.
Failure to ensure that personnel are adequately trained to perform their assigned functions and to document training, as required by 21 CFR 820.25(b). Specifically, employees involved in the manufacturing, packaging, testing, shipping, and complaint handling of in vitro reagents have not been trained in current Good Manufacturing Practice or the use of standard operating procedure template, and you were able to provide documentation of any type of training for only one of your current employees.
Failure to establish and follow document approval, distribution and change procedure, as required by 21 CFR 820.40. For example, standard operating procedure template on how to control approval, distribution, and changes to device master records (DMRs), specifications, device history records (DHRs) and labeling for your strep A and hCG in vitro diagnostics were not available and documents not signed as approved for use were being used in product manufacturing and finished product testing locations during this inspection.
Failure to establish standard operating procedure template to ensure that all purchased or
otherwise received product and services conform to specified
requirements, as required by 21 CFR 820.50. For example, quality
requirements to be met by your contract
manufacturer of your strep A and hCG in vitro diagnostics have not been
defined or documented.
Failure to develop, conduct, control, and monitor production processes to ensure that your devices conform to their specifications, as required by 21 CFR 820.70. For example, you do not have any cleaning standard operating procedure template for the equipment used in the production of strep A and hCG in vitro diagnostics.
Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, are suitable for their intended purposes and are capable of producing valid results, as required by 21 CFR 820.72 (a). Your firm has no approved standard operating procedure template to ensure that equipment is routinely calibrated, inspected, checked and maintained. For example, procedures for calibration, inspection, checks and maintenance of your firm's digital scales, autoclave and spectrophotometer used in the manufacture and testing of your strep A and hCG in vitro diagnostics were not available.
Failure to validate with a high degree of assurance and approve according to established standard operating procedure a process whose results cannot be fully verified by subsequent inspection and test, and failure to document such validation activities and results, as required by 21 CFR 820.75(a). For example, there is no standard operating procedure template in place for validation of your firm's manufacturing process, cleaning operations, software calculations or filling operations for your strep A and hCG in vitro diagnostics.
Failure to use a documented standard operating procedure template for incoming product inspection and acceptance purposes, as required by 21 CFR 820.80(b). For example, there is no documentation of acceptance activities for incoming reagents, reagent bottles, bottle droppers, bottle caps, or labeling for your strep A and hCG in vitro diagnostics. [See inspection observation 13.]
Failure to establish and maintain standard operating procedure for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, and to hold finished devices in quarantine until all activities required by the DMR are completed, as required by 21 CFR 820.80(d). Specifically, entire lots of your strep A and hCG in vitro diagnostics were tested and released after the first day of assembly/production before all activities required in the DMR had been completed. For example, the following lots were released prior to completion of all activities required in the DMR: Mainline Confirms Strep A, lot 94610; Mainline confirms DOTS Strep A, lot 92720; Mainline confirms III hCG serum/urine, lot 96380 and Mainline Maxie pregnancy test urine hCG, lot 418F30.
Failure to establish and maintain standard operating procedure template for implementing corrective and preventive action, as required by 21 CFR 820.100. Specifically, no corrective and preventive action procedures were available during this inspection. Failure to establish and maintain standard operating procedure to control labeling activities to assure that a designated individual has examined labeling for accuracy including, where applicable, the correct expiration date, control number, storage instructions, handling instructions, and any additional processing instructions prior to labeling release for storage or use, as required by 21 CFR 820.120(b). For example, the DHR does not include a date or signature of a person who examined and approved the expiration date and lot numbers on your labels for your Strep A and hCG in vitro diagnostics.
Failure to use documented standard operating procedure template for verification of the label and labeling used for each
production lot in the device history record, as required by 21 CFR
820.120(d). For example, the lot code and expiration labeling for the
Strep A and hCG pregnancy screening test kits are not recorded in the
Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j). For example, you have failed to provide a DHF for any of the devices that your firm manufactures.
Failure to maintain complaint files, and to establish and
maintain a standard operating procedure for receiving, reviewing, and evaluating complaints
by a formally designated unit, as required by 21 CFR 820.198. For
example, you stated that you stopped documenting complaints over a year
ago, and there is no evidence that
complaints 02-05-037, 02-06-004 and 02- 6-023 were reviewed or
Make certain that your validation is up to regulatory compliance requirements by ensuring that this complete chain is in place.