Standard Operating Procedure

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Here a list of available Standard Operating Procedures

• Operation, calibration and maintenance of electronic analytical single pan balances
  

• Aseptic technique guideline for manual operation in a biological safety cabinet, under laminar flow hood or in a clean bench
  

• Hosting regulatory inspections
  

• Creation and use of GMP equipment logbooks
  

• Preventive maintenance (PM) procedure
  

• Annual product review
  

• Supplier certification program
  

• Change control system
  

• Calibration of dissolution test apparatus
  (USP apparatus 1 and 2)
  

• Deviations
  (failure investigations, non-conformance) SOP
  

• Creating, reviewing, approving and issuing an SOP
  

• Calibration program Standard Operating Procedure
  

• Document management
  

• Corrective and preventive action (CAPA)
  

• US NDA field alert
  

• Supplier audit program
  

• Product Recall
  

• Self - internal inspection program
  

• Training
  

• Batch reprocessing and reworking for API
  (active pharmaceutical ingredients)
  

• Investigation of complaints
  

• Handling of OOS results
  

• Returned drug products
  

• Classification evaluation approval of cleaning agents
  

• SOP for refrigerated shipment
  

• Pest control program
  

• Handling of chemicals, reagents and solutions
  in laboratories
  

• Pre Approval Inspection (PAI) protocol for API
  

• Pre Approval Inspection (PAI) protocol for drug products
  

• 21-CFR 820 quality systems checklist
  

• Computer system validation and maintenance checklist
  

• Stability study program / plan - master plan
  

• General rules for laboratories operating under Good Laboratory Practice (GLP)
  

• Site master file (SMF) for drug products
  

• Site master file (SMF) for API - drug substances

• Master plan dossier - maître site (site master file)
  version français
  

• CFR 21 part 11 compliance plan
  

• Validation master plan for solid and
  semi-solid manufacturers
  

• Validation master plan drug substance manufacturing (API)
  

• Qualification master plan for refrigerated shipment
  

• Technical quality agreement for contract manufacturing
  (technical agreement, quality agreement)
  

• Contract manufacturer solids -
  contractor quality questionnaire
  

• Contract testing laboratory - GMP quality questionnaire

• Software Validation Checklist
  

All standard operating procedures puls other GMP templates ditectly on GMP-online-consultancy

SOP Standard Operating Procedure definition

A written document / instruction detailing all steps and activities of a process or procedure. These should be carried out without any deviation or modification to guarantee the expected outcome. Any modification or deviation from a given SOP 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 (SOPs). These SOPs should be the basis for the routine training program of each employee. SOPs 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 SOPs 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 the related SOP. SOPs should be in place for all Quality Systems plus the specific operational activities on site. The structure of an SOP System and the total amount of individual SOPs should be carefully taken into consideration. Too many SOPs could lead to a collapse of the SOP System. System SOPs should not be mixed up to keep systems and interaction between quality systems easy.

The content of a SOP to create SOPs should include the following minimum paragraphs:

• header with titel
• regulatory basis
• reference documents
• purpose
• scope
• responsibilities & accountabilities
  • quality assurance
  • functional units
• procedure
  • layout and format
    • numbering system
    • page header
    • first page
    • table of content
    • SOP content
  • creating a SOP
  • reviewing a SOP
  • signing and approving a SOP
  • issuing a SOP
  • SOP retention time

 

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What is a Statement of Purpose or how to write a Statement of Purpose?

 

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