A standard operating procedure (SOP) is a written set of instructions describing step-wise how a routine activity is to be performed. When the SOP is followed exactly, it ensures consistency of the operation being performed exactly as desired, and this makes sure that the desired quality is attained.
An SOP must contain a straightforward description of the
task to be carried out, in simple language, and cover all the major steps in
performing the task. SOP must be written by persons who have sufficient
knowledge and experience with the task being described.
SOPs must be written in clear language using the active
tense. (For example, “Switch on the equipment..” and not “The equipment is
switched on…”
SOP must be detailed enough to allow someone with even
limited knowledge or experience with the task, to perform the task as desired
without any supervision. However, it must not involve unnecessarily lengthy
descriptions. For example, in some processing SOPs, if equipment operation is
involved, and that procedure is a very long one, and is available in the
equipment operating manual, that procedure may just be referenced in the SOP
instead of repeating all those instructions in the SOP.
Any abbreviations or acronyms used in the SOP must be
explained at the beginning of the SOP.
SOPs must be prepared by the respective departments, and
then reach QA for a review for checking if it complies with cGMP. After QA
approval, the SOP must be signed, dated, and authorized for issue by senior
personnel of the concerned department.
If a need is felt to amend or change any particular in an
existing SOP being used, it must go through the change control procedure
specified as part of QA.
Contents of SOP:
• Title page
• Table of contents
• Procedures
- Scope
- Method Summary
- Definitions
- Health and safety warnings
- Cautions
- Interferences
- Personnel Qualification/Responsibility
- Equipment/supplies
- Procedure in steps
- Calibration/standardization
- Sample collection, handling, and preservation
- Troubleshooting
- Data entry, calculation, and report writing
• QA/QC section
• References section
Common SOPs in a manufacturing unit:
• Organization and personnel
- Personnel qualifications and experience
- Personnel hygiene, responsibilities, movement control
- Personnel training
• Facilities and equipment
- Facility safety procedures
- Facility maintenance and cleaning
- Qualification and validation of critical systems (examples – water system, HVAC, etc.)
- Equipment cleaning and maintenance; log books
- Qualification of equipment
• Materials management
- Receiving and storage of materials
- Sampling of materials
- Control of accepted and rejected materials
- Warehousing of finished products
- Distribution of approved products
• Production
- Work instructions
- Operation of equipment
- All production processes
- All packing processes
- BMR entry and checking
- Personnel safety
- Control of contamination and cross-contamination
- Process deviations report and investigation
- Control of packaging and labeling
• Quality Assurance
- Document control, including SOPs
- MFR and BMR
- Process validations
- Review of batch records and batch release
- Change control
- GMP training
- Corrective and Preventive Action (CAPA)
• Quality Control
- Laboratory safety
- Analytical methods
- Sampling and testing of in-process and final goods
- Calibration of analytical equipment/instruments
- Maintenance of analytical equipment/instruments
- Analytical method validation
- Environmental monitoring
- Approval or rejection of materials
- Investigation of Out of Specifications (OOS) results
- Stability testing