-The Standard Operating Procedures (SOP's) is used to lay out operations consistently and repeatedly in the same repetitive manner. SOP’s must be available for every task that is used in the manufacture or testing of a regulated product. SOP’s ensure that all processes and standard operation procedures are consistently replicated, so even when there are changes in personnel, organizations avoid inconsistencies and do not run unnecessary safety risks.
Standard Operating Procedures or SOP's are written step-by-step procedures 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.
Standard Operating Procedures are active documents that are routinely reviewed and amended as production processes are repaired, altered or replaced. detail written instructions describing specific steps to follow in all activities under defined conditions, they are used to accomplish standardization when performing specific functions and used to ensure approved methodologies are used wherever possible. Having defined all the appropriate standard operating procedures and practices they are then used as audit standards to ensure that these define methods are being meticulously followed and adhered to.
It can be deduced from what is written above that standard operating procedures forms the backbone of regulatory compliance activities in all companies regulated by Good Manufacturing Practices (GMP) rules and regulations.
Having described the use and importance ascribed to Standard Operating Procedures 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.
It therefore becomes pretty obvious and very essential for personnel to be trained in the use of documented standard operating procedures, 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.
1. 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 procedures 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. [See inspection observation 2.]
2. Failure to establish procedures 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 procedures or that quality audits have been performed. [See inspection observation 3.]
3. 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 procedures, and you were able to provide documentation of any type of training for only one of your current employees. [See inspection observation 18.]
4. Failure to establish and follow document approval, distribution and change procedures, as required by 21 CFR 820.40. For example, standard operating procedures 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. [See inspection observations 16 and 17.]
5. Failure to establish standard operating procedures 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. [See inspection observation 5.]
6. 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 procedures for the equipment used in the production of strep A and hCG in vitro diagnostics. [See inspection observation 6.]
7. 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 procedures 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. [See inspection observation 11.]
8. Failure to validate with a high degree of assurance and approve according to established standard operating procedures 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 procedures 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. [See inspectional observation 9.]
9. Failure to use a documented standard operating procedure 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.]
10. Failure to establish and maintain standard operating procedures 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. [See inspection observation 7.]
11. Failure to establish and maintain standard operating procedures 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. [See inspection observation 15.]
12. Failure to establish and maintain standard operating procedures 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. [See inspection observation 10.]
13. Failure to use documented standard operating procedures 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
DHRs. [See inspection observation 8.]
14. Failure to maintain DMRs that include, or refer to the location of, device specifications, as required by 21 CFR 820.181(a). For example, the DMRs for your strep A and hCG in vitro diagnostics do not include or refer to the locations of all specifications for all reagents, bottles, dropper tip caps or dropper tips. [See inspection observation 14.]
15. 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. [See inspection observation 12.]
16. Failure to maintain complaint files, and to establish and maintain standard operating procedures 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 evaluated. [See inspection observation 4.]
Make certain that your validation is up to regulatory compliance requirements by ensuring that this complete chain is in place.
STANDARD OPERATING PROCEDURES.
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The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
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The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.
This Validation, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
This is an essential step forward for companies seeking to reduce validation costs without infringing regulatory standards.
4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation documentation by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
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