Standard Operating Procedures (SOP) are an important part of various standardized management certifications and product certifications, and there are SOP requirements in all industries. What is SOP?Simply put, SOP is a set of all-encompassing operating instructions book. A good set of SOP is necessary to ensure the quality of products or services, SOP is not only a set of technical model, it is more important to cover the management ideas, management concepts and management tools. As in the mature industry, there are clear management norms and certification system, so the standardization and maturity of its SOP are higher, and the preparation of SOP also has a basis for less difficulty. Because there is no mature laboratory management and accreditation system, therefore, the preparation of SOP in the inspection work will be somewhat blind.
First of all, SOP has the characteristics of the industry, different industries have different SOP. in terms of inspection work, the instrument has instrument SOP, reagents have reagent SOP, each project has its own different SOP, not to mention bacteria, biochemistry and immunity of these disciplines have different SOP, is the same discipline within the different projects also have different SOP. so the test SOP is not a, but a set. The first is a set of SOPs, which are not the same as the ones in the other disciplines.
Second, the SOPs are not exhaustive, that is to say, as long as the project is related to, to be detailed and comprehensive, to include all the details that may arise. In the case of the Pilot's Operating Procedures, for example, the first one is "sit down", which shows that the SOPs cover the degree of detail. SOPs are not simple operating instructions, but should be a practical operation of the whole book, and should become the nature of the toolkit things. An ideal set of SOPs should allow a person who doesn't know how to learn to become an expert.
Thirdly, SOPs are not just detailed operating instructions, they are part of a management specification that encompasses quality control and management concepts, from which even staffing can be seen.
While the specific content of different industry SOPs is different, there is a real logical connection, so it is valuable to learn from the SOP requirements of other industries, especially similar industries. Take the pharmaceutical production SOP for example, its requirements are required by the GMP certification, according to the GMP, the focus of its SOP see attached.
Drawing on the focus of the SOP for pharmaceuticals, inspection SOP
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1, operating procedures: experiments and instrumentation operating procedures, access to experimental instruments and experiments after the treatment, cleaning of the experimental table, experimental spillage of the treatment of substances
2, quality control: experiments and instrumentation, such as experimental quality control of the quality of the number of (high, medium, low?), the number of experiments and instrumentation. ) The original record of the experiment is very important, an important means of finding problems and solving problems, in addition to patient information, there should be environmental parameters (weather conditions, temperature and humidity, etc.), the use of instruments and instrumentation, sample traits and quality, reagent manufacturers and batch number, the same batch of quality control results, and treatment (such as rechecking, re-sampling, sending a report), etc., as exhaustive as possible.
3. Abnormal results and processing: judgment of abnormal results of the indicators, and analysis of the reasons for the treatment of when and procedures. For example, is it anomalous to the results, or experimental error or error? How to judge? What is the normal range of the sample? Non-normal range of the specimen if the treatment, greater than how much or less than how much review or contact with the clinic?
4, process: should include the sample receipt and issue, report card receipt and audit, quality and instrumentation problems should have a clear process provisions. Such as who receives the specimen, who sends the report, how much time to receive, how much time to send, to whom to receive, instrument failure reporting procedures and so on.
5, reagents and samples quality indicators, acceptance and storage: who is in, who checks, in what way storage, if the storage quality is correct. Such as: storage refrigerator temperature who monitor, who warns of reagent failure, standard bacteria how long to transfer, etc..
6, personnel duties: personnel duties are clearly reflected in the process such as the process, such as the instrument is broken, who is to report to, who dealt with, who audited the report form, what kind of abnormalities experimental operators to deal with, what kind of report to the supervisor and so on. Of course, there are personnel training SOP better.
Test SOP writing, can be instrument operation manual, reagent instructions for the blue book, according to the department plus upstream and downstream content, such as sample collection and processing, abnormal results of the content can be done for the project or instrument SOP use. Each project SOP plus sample collection, report card issuance, reagent purchase, acceptance and storage, issuance and other SOP will be basically completed.
Highlights of SOPs for pharmaceutical manufacturing
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1 Handling of deviations
Detailed indication and description of when and how for possible deviations from expected results, conclusions, e.g., yield outside the expected range, product out of specification, reaction conditions not in accordance with the specific parameters, substandard equipment, etc., was were studied, what measures, procedures were taken, whether they were reasonable, etc. Scientific test justification, review and approval, etc.
2 Internal Audit
Describe as clearly as possible how, when and by whom the internal audit was conducted and why, what were the methods and procedures adopted, etc.
3 External Audit
Describe the frequency and rationale for auditing suppliers (raw materials, packaging materials, etc.) and the protocols (contracts) used, the shortest and clearest way to do this is by asking the supplier to fill out a self-designed form that includes the above, reviewing and approving the process.
4 Quality Audit Program
Describes how and who reviews and approves batch records, in-process inspections, and final API inspection data, for which the Quality Assurance (QA) department must be ultimately responsible before the finished product reaches the market.
5 Personnel assigned to production to perform intermediate process tests
Describe the protocols and standards that must be met to allow production personnel to perform intermediate process tests, such as verifying the pH of a solution prior to extraction.
6 Criteria for specifications
Describe the people, departments and procedures responsible for reviewing and approving specifications for new raw materials, intermediates and drug products, and if specifications are changed, the review and approval of the protocols should also be addressed in this SOP.
7 Approval of test procedures
Describe the person responsible for the test procedures, departments, test procedures, the test procedures may be the national legal standards, such as the Chinese Pharmacopoeia, the U.S. Pharmacopoeia, the National Formulary of the test procedures is the standard, but if such a procedure does not exist or does not apply to a particular raw material, then the use of other relevant test methods.
8 Approval of control in process protocols
Protocols describing the determining procedures used to control testing in a process.
9 Validation manuals and reports
Describe the rules for issuing, reviewing, and approving process validation manuals and reports.
10 Change control
Describes the work that must be done, review and approval procedures when a process, test method, in-process test, equipment, etc. is changed or will be changed.
11 Sampling Protocol
Describes how the QC department is notified and how samples are collected, identified and transported to the QC room.
12 Approval of Standard Controls
Describes the person and department that selects and approves controls for the process in question.
13 Analytical Studies and Evaluations
Describe the personnel and departments that select and approve analytical studies and evaluations for the relevant process.
14 Test article approval
Describe the personnel and departments that select and approve test articles for the relevant process, including relevant laboratory reports.
15 Commissioned Substance Approval
Describes how to test and use intermediates if they are produced by a third party.
16 Stability Testing
Describe stability testing procedures, including conditions, frequency, data review, and documentation.
17 Contractor Evaluation and Approval
Describes how to select, evaluate, and approve contractors, e.g., commissioning external testing when in-house is not possible.
18 Batch record review
Describe how and by whom production records are reviewed and signed.
19 Complaints Audit
Describes how customer complaints are handled from acceptance to evaluation and to the final response.
20 Use of Out-of-Specification Materials
Describe when the use of out-of-specification materials is permitted and what the approval process entails.
21 Use of Returned Material
Describe what must be done to use returned material and when it is acceptable or unacceptable.
22 Periodic review of SOPs
Describe how often the SOPs are reviewed (usually every two years), who reviews them, and who is involved in approving the review process.
23 Establishment of training records
Describe who receives training, what type of training they receive, who conducts the training, and where the training documentation is kept.
24 Purchase, Receipt, Assaying and Storage of Raw Materials, Intermediates, Packaging Materials and Pharmaceuticals
Describe how all materials are organized and when they are received, inspection procedures (e.g., attached labels), where and how they are stored (in a location separate from the qualifying materials, such as a pending inspection area), and relocated after they are qualified (qualified or non-qualified area). The re-stocking and identification steps also apply to intermediates and pharmaceuticals.
25 Handling of nonconforming material
Describe how the nonconforming material is returned to the supplier (e.g., notify the supplier at the time of purchase and prepare documentation) and where it is stored until it is shipped.
26 Labeling Control
Describe how labels are printed, maintained, controlled, and shipped to the appropriate departments such as production when needed. (Note: The area where labels are kept must be kept out of the way and the amount of labels must be strictly controlled.)
27 Change of work clothes
Describe who must change into work clothes (e.g., uniforms for operators and lab coats for supervisors), when and where they must be changed, and how often they must be distributed and changed.
28 Control of air and water systems
Describe who and what is responsible for inspecting the ventilation used and all water systems at what intervals (including its process, deionized water that meets microbiological analysis and endotoxin specifications).
29 Laboratory and Production Area Piping System Identification
Describes the system used to identify all laboratory and production area piping, which can be a mix of color codes, arrows, written instructions, labels, etc.
30 Cleaning Protocols for Production Equipment, Vessels, and Containers
Describe the validated and approved methods for cleaning each piece of equipment. (If the protocol for cleaning several reactors is the same, then writing down one protocol describing such cleaning would encompass the cleaning of all reactors.)
31 Maintenance of production equipment
Describe how often and what needs to be done to keep the equipment functioning properly. (Records need to be kept for each piece of equipment and describe what was done and by whom at the time of the last maintenance.)
32 Protection and Inspection of Equipment in Use
Describe how equipment that has been idle between uses has been cared for and the inspections that must be made before it can be used again, also record the maximum time experienced in idleness (not to exceed 10 days or the need for re-cleaning).
33 Cleaning Validation Protocol
Describe how the cleaning validation protocol was developed, who reviewed and approved it, and where the documentation is kept. (Content should include frequency of intervals for residue, cleaner, and bioburden control.)
34 Equipment Calibration
Describe what equipment is calibrated, how often it is recalibrated, who performs the calibration, how it is labeled, and where the records are kept.
35 Equipment that is not used or fails calibration
Describe how to identify equipment that is not used because it fails calibration and needs repair, maintenance, etc.
36 Validation of computer systems
Details some of the criteria for when a computer system is used in a production process and needs to be validated. The main elements that are verified are: operation of the system, measures taken to prevent failures, checking for errors, correcting records, restarting and recovering data, authorizing changes, recording changes, electronic signatures, checking the accuracy of manually entered data, backing up data, user rights, etc.
36 Computer system verification
Details some of the criteria for when a computer system is used in a production process and needs to be verified.
37 Equipment Logs
Logs used to describe what equipment was used and what products were produced. Note: This is not necessary for specialized equipment. These are generally included in the batch production record.
38 Maintenance of Main Production and Control Records
Describes how the main production records (blank batch records) and analytical records (quality control test protocols) are maintained and controlled, and requires that the main production records should be kept by the QA department in an appropriate place.
39 Maintenance of complete production and control records
Describes how complete production records (complete batch records) and analytical laboratory records (analytical reports) are maintained, and requires that complete batch records and analytical test reports should be maintained and controlled by the quality assurance department.
40 Re-test cycles for all raw materials and intermediates
Detail how often and which raw materials must be re-tested. For example: hydrochloric acid after being tested and qualified, approved for a period of two years, if by then not all the material has not been used, the remaining before use must be re-inspected. Qualified can be extended to use, otherwise for scrap processing.
41 Mixing Multiple Batches
Describe how to mix multiple batches. If a batch is to be mixed, each batch must be inspected and pass all of the standard parameters before it can be mixed with other batches. Mixing multiple batches of API should be avoided unless absolutely necessary.
42 API Labeling Identification
Describes how to label the finished product. A copy of the label should be included in the SOP. (A damaged label surface cannot be used.)
43 Batch Production Traceability
Describe the system and operational procedures by which a given batch of raw materials or intermediates can be traced in the event of a problem after use. This system needs to be more rigorous if the material in question is to be recovered.
44 Resampling and Retesting of Raw Materials, Intermediates, and APIS Once Nonconformities are Detected
Detail the circumstances under which a raw material, intermediate, or API is retested once a nonconformity has been detected, including how the retesting is performed and reuse is permitted.
45 Validation of Analytical Protocols
Describes the characteristics that should be considered when validating analytical protocols, including accuracy, precision, specificity, limit of detection, limit of quantification, linearity, range, and sloppiness.
46 Notifying Customers of Changes to Defined Manufacturing and Process Control Protocols
Describe how and when to notify customers if changes are made or are expected to be made to defined manufacturing and control protocols. Note the distinction between minor, major, and critical changes.
47 Inspection and Certification of Reworked APIs
When inspecting and certifying reworked APIs, any discrepancies need to be analyzed. For example, the criteria that caused the API to fail are critically analyzed and evaluated.
48 Mixing of freshly formulated and recovered solvents
Describing how to store and use freshly formulated and recovered solvents, mixing freshly formulated and recovered solvents in storage drums is highly inadvisable, and they should only be mixed when they are added to a batch, and must be qualified according to their respective specifications before use.
49 Recycling of APIS
Describe what must be done and who must be notified when it is decided that recycling is necessary.
50 Drugs for Clinical Trials
Describe the quality control measures applied to the production of drugs for clinical trials and the contents of the Good Manufacturing Practice (GMP). Note: The quality standards are the same as those for pharmaceutical raw materials for formal production.