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Standard Operating Procedures

This chapter deals with the standard format that is recommended for this type of documentation. The first SOP that is required to be written down is the procedure for creating, amending and maintaining these documents. Adherence to the instructions of the SOP will ensure compliance with the rules.

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Werner Schrammel
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245 views2 pages

Standard Operating Procedures

This chapter deals with the standard format that is recommended for this type of documentation. The first SOP that is required to be written down is the procedure for creating, amending and maintaining these documents. Adherence to the instructions of the SOP will ensure compliance with the rules.

Uploaded by

Werner Schrammel
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Good Manufacturing Practices

Chapter 4: Standard Operating Procedures


What are Standard Operating Procedures?
Throughout the texts of the GMP Rules, Regulations and Guidelines published by the various regulatory authorities appears the requirement that procedures, processes and methods be written down, so that comprehensive documentation of the means of manufacture and testing of a specific drug product will exist. This requirement often includes the statement, these procedures shall be followed. Thus the creation of standard operating procedures, and their observation, is a GMP legal requirement. This chapter deals with the standard format that is recommended for this type of documentation. In fact, the first Standard Operating Procedure (SOP) that is required to be written down is the procedure for creating, amending and maintaining these documents. SOPs are not archives, merely to be kept in a filethey are living documents which must be kept completely up to date and must be available to any member of the staff who is responsible for performing any process or procedure covered by GMP rules. One must comply with SOPs. Every topic that GMP regulations cover can be dealt with by the creation of a suitable SOP, and adherence to the instructions of the SOP will ensure compliance with the rules. Thus the Quality Control and Assurance Unit of the manufacturer will have five SOP responsibilities: Writing the primary SOP on SOP creation, revision and approval Ensuring that SOPs are created according to the agreed procedures Maintaining a file of all past and current SOPs Ensuring that all operatives have copies of current SOPs relating to their work Ensuring that all operatives follow the procedures laid down, by auditing records and inspecting the facility and its operations The GMP regulations specify that the SOPs must describe procedures, processes and methods that management is satisfied will assure the quality and integrity of the product manufactured and the data generated in the course of quality control testing. Any significant change in any operating procedure has to be properly authorized in writing by management. A further discussion of the managerial responsibilities for SOP and GMP in general will be found in Chapter 6.

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Good Manufacturing Practices

Guide to Writing SOPs


Given the importance of the SOPs, it is advisable to expend some serious effort to lay down means for creating and maintaining these in as rational and useful a form as possible. The bench-level operator must be able to understand and easily follow the SOP covering his or her work in order to be able to comply. The writing of clear, easily followed SOPs is an art which must be acquired by those responsible for this task. A list of the minimum set of SOPs needed in the average GMP facility is given in below; it can be seen to be quite exhaustive. The following guidelines may assist in the writing of effective SOPs: Use a standard format for all SOPs this can be based on the familiar layout used for writing scientific reports, but with certain additions or deletions, as appropriate (Exhibits 4.1 and 4.2). The format should include the following items: Title: e.g. Compounding of Formula xxx or Potency test for Measles Vaccine, or Cleaning of Centrifugal Separator Model XYZ123, with Version Number. Date of original version & author. Dates of any revisions and authors. Record of the approval process for each version. Definition of staff responsibilities for the procedure, by position description Short description of the procedure: e.g. This SOP describes the weighing and mixing of the ingredients used to make Formula xxx. Materials needed: Apparatus used, chemicals, cleaning solutions, tools, control samples, reference standards, etc. Methods: The description of the procedures should include: all safety precautions to be taken when the procedure is to be applied; the exact description of all stages of the procedure; sampling for QC, if required; the operating or test data to be recorded; the check points; the records to be kept; the standards to be complied with; the labeling to be applied to the materials under process and any samples taken and the eventual destination of the material and samples. If a QC test is the subject, the SOP covers all stages of the test; the observations or readings to be taken and recorded; the analysis and the interpretation of the results. Result to be reported (if appropriate): This could be as little as pH of Final Solution = 7.45, or with details such as Potency calculated as 416 units/mg., with Standard calculated at 105 U/mg. within acceptable limits. Where dated signatures are to be applied: e.g., of operator against every step in the process, with second signature where required, e.g.: in the checking of weighing, countersigned by supervisor. Conclusion: Could be a simple statement, such as Test Passed or may indicate further
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