Standard Operation Procedures

View as Grid List

27 Items

per page
Set Descending Direction
  1. Change Control System - GMP SOP
    Change Control System - GMP SOP
    Rating:
    100%
    Regular Price $120.00 Today $99.00
    + german VAT when applicable
    In stock
  2. Deviations (Failure Investigations, Non-Conformance) - GMP SOP
    Deviations (Failure Investigations, Non-Conformance) - GMP SOP
    Rating:
    100%
    Regular Price $95.00 Today $79.00
    + german VAT when applicable
    In stock
  3. Pest Control Program - GMP SOP
    Pest Control Program - GMP SOP
    Rating:
    100%
    Regular Price $120.00 Today $89.00
    + german VAT when applicable
    In stock
  4. Handling Of Chemicals, Reagents And Solutions In Laboratories - GMP SOP
    Handling Of Chemicals, Reagents And Solutions In Laboratories - GMP SOP
    Rating:
    100%
    Regular Price $70.00 Today $49.00
    + german VAT when applicable
    In stock
  5. Product Recall - GMP SOP
    Product Recall - GMP SOP
    Rating:
    100%
    Regular Price $140.00 Today $119.00
    + german VAT when applicable
    In stock
  6. Supplier Certification Program - GMP SOP
    Supplier Certification Program - GMP SOP
    Regular Price $90.00 Today $79.00
    + german VAT when applicable
    In stock
  7. Preventive Maintenance (PM) Procedure - GMP SOP
    Preventive Maintenance (PM) Procedure - GMP SOP
    Regular Price $100.00 Today $89.00
    + german VAT when applicable
    In stock
  8. Annual Product Review - GMP SOP
    Annual Product Review - GMP SOP
    Regular Price $120.00 Today $99.00
    + german VAT when applicable
    In stock
  9. Training - GMP SOP
    Training - GMP SOP
    Regular Price $120.00 Today $99.00
    + german VAT when applicable
    In stock
  10. Corrective and preventive action (CAPA) - GMP SOP
    Corrective and preventive action (CAPA) - GMP SOP
    Regular Price $120.00 Today $99.00
    + german VAT when applicable
    In stock
  11. GMP Document Management - GMP SOP
    GMP Document Management - GMP SOP
    Regular Price $100.00 Today $89.00
    + german VAT when applicable
    In stock
  12. Handling Of OOS Results - GMP SOP
    Handling Of OOS Results - GMP SOP
    Regular Price $120.00 Today $99.00
    + german VAT when applicable
    In stock
  13. Investigation Of Complaints - GMP SOP
    Investigation Of Complaints - GMP SOP
    Regular Price $120.00 Today $99.00
    + german VAT when applicable
    In stock
  14. Self-Inspection Program - GMP SOP
    Self-Inspection Program - GMP SOP
    Regular Price $100.00 Today $79.00
    + german VAT when applicable
    In stock
  15. Calibration Program - GMP SOP
    Calibration Program - GMP SOP
    Regular Price $160.00 Today $139.00
    + german VAT when applicable
    In stock
  16. NDA Field Alert - GMP SOP
    NDA Field Alert - GMP SOP
    Regular Price $120.00 Today $99.00
    + german VAT when applicable
    In stock
  17. HPLC Calibration - GMP SOP
    HPLC Calibration - GMP SOP
    Regular Price $180.00 Today $149.00
    + german VAT when applicable
    In stock
  18. Supplier Audit Program - GMP SOP
    Supplier Audit Program - GMP SOP
    Regular Price $100.00 Today $89.00
    + german VAT when applicable
    In stock
  19. Creating, Reviewing, Approving And Issuing an SOP - GMP SOP
    Creating, Reviewing, Approving And Issuing an SOP - GMP SOP
    Regular Price $140.00 Today $129.00
    + german VAT when applicable
    In stock
  20. Refrigerated Shipment - GMP SOP
    Refrigerated Shipment - GMP SOP
    Regular Price $110.00 Today $89.00
    + german VAT when applicable
    In stock
  21. Classification Evaluation Approval Of Cleaning Agents - GMP SOP
    Classification Evaluation Approval Of Cleaning Agents - GMP SOP
    Regular Price $90.00 Today $79.00
    + german VAT when applicable
    In stock
  22. Returned Drug Products - GMP SOP
    Returned Drug Products - GMP SOP
    Regular Price $100.00 Today $89.00
    + german VAT when applicable
    In stock
  23. Batch reprocessing and reworking for API (active pharmaceutical ingredients) - GMP SOP
    Batch reprocessing and reworking for API (active pharmaceutical ingredients) - GMP SOP
    Regular Price $120.00 Today $89.00
    + german VAT when applicable
    In stock
  24. Calibration of dissolution test apparatus (USP apparatus 1 and 2)
    Calibration of dissolution test apparatus (USP apparatus 1 and 2)
    Regular Price $150.00 Today $129.00
    + german VAT when applicable
    In stock
  25. Hosting Regulatory Inspections - GMP SOP
    Hosting Regulatory Inspections - GMP SOP
    Regular Price $220.00 Today $199.00
    + german VAT when applicable
    In stock
  26. Operation, Calibration And Maintenance Of Electronic Analytical Single Pan Balances - GMP SOP
    Operation, Calibration And Maintenance Of Electronic Analytical Single Pan Balances - GMP SOP
    Regular Price $120.00 Today $99.00
    + german VAT when applicable
    In stock
View as Grid List

27 Items

per page
Set Descending Direction

The term or abbreviation SOP - Standard Operation Procedures is widely used but specifically in the manufacture of drug products, APIs (Active Pharmaceutical Ingredients), biologics, devices and the food and cosmetic industry.

Standard Operating Procedures (SOPs) must be written, approved and followed for any operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient, medicinal product or medical devices to ensure consistent application.

Standard Operating Procedure (SOP)
An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature (e.g., equipment operation maintenance and cleaning, validation, cleaning of premises, environmental control, sampling and inspection, specific departmental activities, distribution activities). Certain SOPs may be used to supplement product-specific master and batch production documentation or distribution records. 

Standard Operating Procedure (SOP) Management 

A formal program at a site to ensure development, maintenance and archiving of SOPs for compliance to GMPs.

The Site Management Team must ensure that there are systems for creating, approving, maintaining and archiving Standard Operating Procedures for those
activities that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient or medicinal product.

Site Management must ensure that there is a system in place for training personnel on the Standard Operating Procedures applicable to their area of responsibilities.

The Site Quality Manager must approve all systems for creating, approving, and maintaining Standard Operating Procedures.

The site Quality Manager is responsible for approving or rejecting all site procedures that may potentially impact on the identity, strength, quality and purity or distribution of active pharmaceutical ingredient or medicinal product.

Forms and flow charts are recommended to improve understanding and facilitate use of
Standard Operating Procedures. When forms, flow charts and any other attachments
are used, they must be either:

  • managed as an integral part of the SOP (i.e. any revision(s) to the forms, flow charts and in general any SOP attachment requires a revision of the Standard Operating Procedure)
  • or follow their own review and approval process. In that case, the impact of any revision of the form, flow chart or attachment on the associated SOP must be evaluated and vice versa.

Standard Operating Procedures must be written in a language that is understood by the user.


Standard Operating Procedures relevant to the activity must be available at the workplaces, as well as the current version of the forms, flow charts or other attachments to be used.

Measures must be taken to ensure that the copies, which are to be distributed, are identical to the original Standard Operating Procedure and distribution control must be maintained for “approved copies” or “paper copies”.

A system must be in place to ensure that superseded SOPs are removed and destroyed except for the approved signed originals that are archived according to document retention requirements.

There must be systems and procedures for Standard Operating Procedures that must
include at a minimum:

  • The format, content and numbering of the procedures
  • The purpose and scope of the procedures
  • The generation, review and approval of the procedures
  • The distribution mechanism for the procedures which includes addressing control of
  • paper copies
  • The training mechanism for new or revised procedures
  • The revision, versions and change history of procedures managed by change control
  • The archiving and retrieval of superseded procedures
  •  The management of forms or record sheets associated with procedures


Standard Operating Procedures must be written in sufficient detail so that the govern process is reliably repeated using only the procedure and attachments.


Personnel writing or reviewing procedures must have the expertise in the area, function or activity covered in the procedure and training in applicable Good Manufacturing Practice or related regulations.


Procedures must be clearly written, understandable by persons who are to follow them, and complete.
Procedures must be reviewed, and if necessary revised, at least every three two to ensure that the procedure is still valid. 
If a revision is not needed the procedure must clearly show that it has been reviewed and its validity extended for another period.

A minimum set of Standard Operating Procedure should be available in GMP manufacturing areas for the following systems:

Quality management
Deviation and change control
Training and organization
Complaints
Recalls
preventive maintenance
The release of raw materials and finished goods
Out of specification results
Environmental monitoring
Material management and goods receipt
Pest control
QC testing
In process control IPC testing
Document management
The creation of SOPs
Corrective and preventive actions
Format and content of batch records
Qualification and validation
Setting up product specifications
Supplier qualification
Internal audit or the self inspection program
Lot numbering process

Do you want
15% OFF
Your first order?
Your coupon is below!
Coupon: df56s5d8