SOPs for Drug Products

The pharmaceutical industry is heavily regulated by a wide range of authorities such as the Food and Drug administration (FDA) in the United States and the European Medicine Agency (EMA). Drug Product, a finished dosage form like a tablet, capsule, or solution containing a drug substance, needs to meets local laws and globally harmonized directives and guidelines, as well as the concurrent (c)GMP (Good Manufacturing Practices), which is seen as the state of the art standard by the authorities. For your successful business you must comply with the current GMPs. Our Standard Operating Procedures (SOPs) and templates are built on the requirements of 21 CFR (Code of Federal Regulations) part 210 and 211 as well as the European directives and a number of international organizations and standardization initiatives like ICH, WHO, PIC/S. Our document portfolio consists of a wide range of documents, templates and forms helping you to meet these regulatory expectations.

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  1. Change Control SOP

    Change Control SOP

    This Standard Operating Procedure (SOP) for a well structured Change Control Process is ready to use and meets authorities’ expectations. The 10-page SOP includes a 2 pages template and only needs some minor modification before it can be followed by your personnel and guarantees an effective Change Control system.

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    $110.00

  2. SOP on Standard Operating Procedures

    SOP on Standard Operating Procedures

    This Standard Operating Procedure (SOP) describes the Process on how to write SOPs. Standard Operating Procedures (SOPs) must be written, approved and followed for any routine operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient, pharmaceutical product (i.e. drug product) or medical devices to ensure consistent application and meet regulatory compliance. The purpose of this Standard Operating Procedure (SOP) is to standardize and systematize the creation, revising, approving and issuing of Standard Operating Procedures.

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    $150.00

  3. Complaint Handling - Customer Complaints

    Complaint Handling - Customer Complaints

    This Standard Operating Procedure (SOP) describes the Complaint Handling program, all necessary steps, starting from the notification recording, investigation and subsequent actions, which must be carried out for any customer complaint received.

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    $190.00

  4. Training Program SOP

    Training Program SOP

    This Standard Operating Procedure (SOP) describes the Training program for Company personnel to acquire the skills, knowledge and qualifications necessary to perform effectively the duties and tasks for which they are employed.

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    $130.00

  5. Internal Audit

    Internal Audit

    This Standard Operating Procedure (SOP) describes the program necessary to assure compliance with all relevant GMP and Regulatory Requirement. Therefore this SOP defines the procedure and responsibility for the Internal Audit (Self-inspection) planning, implementation and follow-up to assure Site’s compliance with regulatory, cGMP and Site quality procedures.

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    $140.00

  6. Product Recall Management

    Product Recall Management

    This Standard Operating Procedure (SOP) describes the program necessary to assure that a product recall is conducted prompt, complete and in accordance with any governmental health agencies regulations and requirements of distributed product that is suspected or known by management to be seriously defective, and/or pose potential health risk to patients.

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    $180.00

  7. Quality Product Review / Annual Product Review

    Quality Product Review / Annual Product Review

    This Standard Operating Procedure (SOP) describes the program necessary when conducting the Annual Product Review (APR) which must be performed for each commercial product. The purpose of this SOP is to provide clear guidance on how to perform an APR with the purpose to verify the consistency of the process, to assess trends, to determine the need for changes in specifications, production, manufacturing, and/or control procedures and to evaluate the need for revalidation.

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    $190.00

  8. CAPA Program SOP

    CAPA Management

    This Standard Operating Procedure (SOP) describes the program necessary for the Corrective and Preventive Action (CAPA) Program. The purpose of this document is to provide clear guidance for Quality and personnel working in a GMP environment when conducting CAPAs. The CAPA system in addition assures the tracking and trending of actions and issues requiring mid-term and long-term corrective actions. This procedure will provide guidance on the requirements and the use of the system as well as the procedure for processing CAPAs.

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    $180.00

  9. Vendor, Supplier and Contractor Audit

    Vendor, Supplier and Contractor Audit

    This procedure pertains to GMP related Audits of suppliers of raw materials, excipients or components, drug products, drug substances and medical devices, contract manufacturing and services, contract laboratory testing, contract packaging or labeling facilities. All of these service providers are called in the SOP “suppliers”. Learn More
    $180.00

  10. Deviations and Non-Conformances SOP

    Deviations and Non-Conformances SOP

    This Standard Operating Procedure (SOP) describes the program necessary to ensure that all Deviations are documented, investigated within 30 working days,  assessed by the responsible line units and Quality Assurance (QA), corrective actions if applicable are implemented and implementation is tracked, the complete process is managed, monitored and controlled.

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    $160.00

  11. Supplier Approval, Qualification and Certification SOP

    Supplier Approval, Qualification and Certification SOP

    This Standard Operating Procedure (SOP) describes the program necessary to ensure qualifying a supplier is to assess the supplier’s reliability, continuous quality of products and services and the overall effectiveness of the supplier’s quality assurance system. This SOP describes the complete process in a step-by-step approach to qualify a supplier from an approved to a certified status.

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    $120.00

  12. Standard Operating Procedure Template - SOP Template

    Standard Operating Procedure Template - SOP Template

     This is an empty SOP template to create site specific standard operating procedures. It contains all relevant section headers of an up to date operating procedure.

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    $9.90

  13. Preventive Maintenance

    Preventive Maintenance

    This Standard Operating Procedure (SOP) describes the Process on how to manage the Preventive Maintenance Program. The SOP describes the processes for requesting, conducting and managing the overall Preventive Maintenance (PM) activities.

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    $120.00

13 Item(s)

per page
Set Descending Direction