Standard Operating Procedures

SOPs for Phamaceutical Manufactures operating under
Good Manufacturing Practice (GMP) or GxP

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Here a list of available Standard Operating Procedures SOPs :

• Standard Operating Procedure for the operation, calibration and maintenance of electronic analytical single pan balances
  download here

• Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench SOP
  download here

• Standard Operating Procedure for hosting Regulatory Inspections - SOP
  download here

• Standard Operating Procedure for the creation and use of GMP equipment logbooks - SOP
  download here

• Standard Operating Procedure for preventive maintenance (PM) procedure - SOP
  download here

• Annual product review SOP
  download here

• Supplier certification program SOP
  download here

• Standard Operating Procedure for change control system - SOP
  download here

• Standard Operating Procedure for calibration of dissolution test apparatus
  (USP apparatus 1 and 2)
  download here

• Standard Operating Procedure for Deviations
  (failure investigations, non-conformance) SOP
  download here

• Standard Operating Procedure for creating, reviewing, approving and issuing an SOP
  download here

• Calibration program Standard Operating Procedure
  download here

• GMP document management Standard Operating Procedure
  download here

• Corrective and preventive action (CAPA) Standard Operating Procedure
  download here

• US NDA field alert Standard Operating Procedure
  download here

• Supplier audit program Standard Operating Procedure
  download here

• Product Recall Standard Operating Procedure
  download here

• Self - internal inspection program Standard Operating Procedure
  download here

• Training Standard Operating Procedure
  download here

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

• Investigation of complaints Standard Operating Procedure
  download here

• Handling of OOS results Standard Operating Procedure
  download here

• Returned drug products
  download here

• Classification evaluation approval of cleaning agents
  download here

• SOP for refrigerated shipment
  download here

• Pest control program SOP
  download here

• Handling of chemicals, reagents and solutions
  in laboratories SOP
  download here

• Pre Approval Inspection (PAI) protocol for API
  download here

• Pre Approval Inspection (PAI) protocol for drug products
  download here

• 21-CFR 820 Quality systems checklist
  download here

• Computer system validation and maintenance checklist
  download here

• Stability Study Program / Plan - Master Plan
  download here

• General Rules for Laboratories Operating under Good Laboratory Practice (GLP)
  download here

• Master Plan Site master file (SMF) for drug products
  download here

• Master Plan Site master file (SMF) for API - drug substances
  download here

• Master Plan Dossier-Maître Site (Site Master File)
  Version Français
  download here

• CFR 21 Part 11 compliance plan
  download here

• Validation master plan for solid and
  semi-solid manufacturers
  download here

• Validation master plan drug substance manufacturing (API)
  download here

• Qualification master plan for refrigerated shipment
  download here

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

• Contract manufacturer solids -
  contractor quality questionnaire
  download here

• Contract testing laboratory - quality questionnaire
  download here

All Standard Operating Procedures puls other GMP Templates ditectly on GMP-Online-Consultancy

Information on general GMP Quality Aspects and about the Food and Drug Administration FDA on GMP Quality

SOP - Standard Operating Procedure

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 times