SOP (STANDARD OPERATING PROCEDURE ).SOP Rationale.This Standard Operating Procedure details the layout and scope that must be followed when authoring a Standard Operating Procedure, and as such is an essential regulatory required document. Since this document is the backbone of the pharmaceutical and medical device industry, there must be an Standard Operating Procedure on how to write a Standard Operating Procedure. All actions carried out in the cGMP manufacturing process of a product, must be executed in accordance with written instructions, if the manufacture of the product is to be cGMP compliant. The vast majority of these actions are detailed in prodedure documents. The Food and Drug Authority (FDA) and Health and Medicines Regulatory Authority (HMRA), regulators insist on this, yet they have not defined a layout or dictated the content of this document. However they have let everyone know that they must be clear and concise, and must not be confusing, ambiguous or lack definition. The FDA is less interested in the layout and style of the document than whether it is being followed and a good level of compliance is being maintained. Part of the execution of the Operational Qualification is the verification that SOP’s are in place covering every aspect of equipment usage. the Product Qualification execution must also be carried out strictly in accordance with the relevant procedure document. Effective SOPs are essential not only for establishing and maintaining ongoing compliance with cGMP and FDA requirements, but also for meeting your business goals in terms of operational performance, enhanced quality, and efficiency improvements. Procedure documents describe and regulate your processes throughout the different levels of the enterprise, and the individual stages of the drug life cycle.
GO TO DOCUMENT SHOP AND SELECT THIS DOCUMENT FOR IMMEDIATE DOWNLOAD. In general, writing procedures force a person to think through a procedure step by step and to standardize the materials and methods. The exercise of writing the procedure document is a regulatory requirement. The document itself, once reviewed and approved will become your company’s official procedure for the task covered, as required in compliance with regulations (e.g., Good Laboratory Practices, Food and Drug Administration, 40 CFR 160.81). A good procedure document is be brief and succinct; the shorter, the better. Anyone - student, support staff, post-doc or principal investigator, can prepare them. The document must be available to operators and must be followed to the letter. PROCEDURES SCOPE.This Standard Operating Procedure will guide you into constructing documents that are simple, easy to follow and compliant. If you're SOP’s do not have these combined attributes, then you are not cGMP compliant. The headings listed below are the standard headings Validation Online uses in our documents. They must be approved by competent persons before use.
SOP (STANDARD OPERATING PROCEDURE)
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