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Operation, calibration and maintenance of electronic analytical single pan balances
Calibration of dissolution test apparatus
(USP apparatus 1 and 2)
Deviation
(failure-investigations, non-conformance)
Supplier audit program Standard Operating Procedure Template
Batch reprocessing and reworking for API
(active pharmaceutical ingredients)
Handling of chemicals, reagents and solutions
in laboratories
General rules for laboratories operating under Good Laboratory Practice (GLP)
Master plan dossier - maître site (site master file)
version français
Validation master plan for solid and
semi-solid manufacturers
Technical quality agreement for contract manufacturing
(technical agreement, quality agreement)
Contract manufacturer solids -
contractor quality questionnaire
All Standard Operating Procedures puls other GMP templates ditectly on GMP-online-consultancy
Is a written document / instruction detailing all steps and activities of a process or procedure. The SOP should be carried out without any deviation or modification to guarantee the expected outcome. Any modification or deviation should be thoroughly investigated and outcomes of the investigation documented according the internal deviation procedure. All quality impacting processes and procedures should be laid out in Standard Operating Procedures. They sould be the basis for the routine training program of each employee. Procedures should be regularly updated to assure compliance to the regulatory requirements and the working practice. A minimum review schedule of 3 years is recommended. Changes of these documents are in general triggered by process or procedural changes / adjustments. These changes should be managed by the internal site change control procedure. Part of the activity list of such changes should be to update. SOPs should be in place for all Quality Systems plus the specific operational activities on site. The structure of a procedural System and the total amount of individual documents should be carefully taken into consideration. Too many could lead to a collapse of the whole System. System instructions or directives or policis should be not mixed up to keep interaction between quality systems easy.
How to build a SOP Tempalte?
The content of a Standard-Operation-Procedure should include the following minimum paragraphs:
What is a Statement of Purpose?
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