GMP SOP CONTENT Power Package

This package contains 18 content elements (125+ pages) related to CAPA, complaint handling, internal audits, batch records, quality agreements and SOP on SOPs, including: 7 SOP templates (55 pages), 4 SOP template auditing checklists (20 pages), 3 Forms(3 pages), 2 Other Templates (11 pages), 1 PowerPoint Training Presentation and Trainer Instructional Notes (30 pages) and 1 Article (8 pages):

CAPA

➢ 1. CAPA SOP

➢ 2. CAPA SOP Auditing Checklist

Complaint Handling

➢ 3. Complaint Handling SOP

➢ 4. Complaint Handling SOP Auditing Checklist

Internal Audits

➢ 5. Conducting Effective Internal Audits SOP

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➢ 6. Audit Report Template

Batch Records

➢ 7. Batch Record Review SOP

➢ 8. Attachment 1: Batch Record Review Audit Checklsit

➢ 9. Attachment 2: Quality Disposition Form

Quality Agreements

➢ 10. Quality Agreements SOP

➢ 11. Active Pharmaceutical Ingredient (API) Product Quality Template

SOP on SOPs Training and Auditing Templates include:

➢ 12.Preparation, Content, Administration and Review of Standard Operating Procedures

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➢ 13.SOP on SOPs Template

➢ 14.SOP on SOPs Checklist

➢ 15.SOP on SOPs PowerPoint Training Presentation and Trainer Instructional Notes

➢ 16.SOP on SOPs Functional Unit Designations FORM

➢ 17. SOP on SOPs Request FORM

➢ 18.Standard Operating Procedures for GXP Operations: Practical Applications in FDA-Regulated Industry (Article)

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CAPA

1. CAPA SOP

This nine (9) page procedure contains over 40 proposed actions related to all activities involving CAPA identification, initiation, management, control, monitoring, closure and oversight for all production and quality operations administered by the company site. The procedure section of the SOP includes subject matter related to the following topics, including:

➢Identification of CAPA through incident

➢Identification of CAPA through periodic datastream analysis

➢Root cause identification/investigation

➢Identification and assignment of corrective actions

➢Identification and assignment of preventive actions

➢CAPA prioritization and timeliness

➢CAPA closure and effectivity checks

➢CAPA communication, reporting and monitoring

➢CAPA escalation

2. CAPA SOP Auditing Checklist

This five (5) page checklist includes 26 functional requirements and points to consider related to verifying that requirements identified in the Creating an Effective CAPA System SOP for development, implementation and training are implemented.

Complaint Handling

3. Complaint Handling SOP

This nine (9) page procedure contains 50 proposed actions related to defining specific receipt, assessment, investigation documentation and monitoring requirements for product quality complaints. The procedure section of the SOP includes subject matter on the following topics, including:

➢ Receipt of complaints

➢ Complaint tracking system

➢ Medical assessment

➢ Quality assurance assessment

➢ Complaint investigation

➢ Corrective And Preventive Action (CAPA)

➢ Complaint close-out

➢ Complaint file documentation

➢ Complaint trending

4. Complaint Handling SOP Auditing Checklist

This six (6) page checklist contains 30 functional requirements and points to consider related to verifying that requirements identified in the SOP on Complaint Handling for development, implementation and training are implemented.

Internal Audits

5. Conducting Effective Internal Audits SOP

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➢ Audit scheduling

➢ Execution of the internal audit

➢ Audit frequency and continued audit scheduling

➢ Internal audit close out

➢ Actions for continuation of internal audits

Also includes a two (2) page attachment: Audit Report Template

6. Audit Report Template

Batch Records

7. Batch Record Review SOP

This six (6) page SOP contains 37 proposed actions which describe the process for review and approval of cGMP documentation for master production records and executed production records. This procedure applies to clinical and commercial documentation supporting cGMP activities, all batch record-related cGMP documentation received, commercial product, or clinical product purposes.

8. Attachment 1: Batch Record Review Audit Checklist

This three (3) page checklist contains 44 audit items related to batch record review, including:

➢ Master batch records

➢ All executed batch records

➢ Executed blister packaging records

➢ Executed bottle packaging records

➢ Executed label printing and labeling records

9. Attachment 2: Quality Disposition Form

One (1) page in length.

Quality Agreements

10. Quality Agreements SOP

This four (4) page SOP includes providing standards for content and process used in the development and approval of a Quality Agreement with Contract Manufacturing Organizations (CMO).

The procedure section of the SOP includes subject matter related to the following topics, including:

➢ Development of the quality agreement

➢ Determination of need for the quality agreement

➢ Review of the quality agreement

➢ Approval and issuance

➢ Training

➢ Maintenance

Includes an attachment-Active Pharmaceutical Product Quality Agreement template.

11. Active Pharmaceutical Ingredient (API) Product Quality Template

This nine (9) page document establishes a Quality Agreement between Contracting Company Name and Contract Manufacturing Organization (CMO) regarding the manufacturing and supply of Drug Name Active Pharmaceutical Ingredient (API). This agreement outlines the responsibilities of Contracting Company Name and CMO Company with respect to the quality of the above drug substance, and the interface between the companies.

SOP on SOPs Training and Auditing Templates include:

12.Preparation, Content, Administration and Review of Standard Operating Procedures

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SOP includes critical procedural areas:

➢Development of New SOPs

➢Composition

➢Notice of Review

➢Approval

➢Effective Date and Distribution

➢Periodic Review and Revision

➢SOP Deviations

➢...and more

13.SOP on SOPs Template

14.SOP on SOPs Checklist

This 19 item, six (6) page checklist is designed to verify that requirements identified in the SOP template for development, implementation and training on SOPs are correctly implemented.

15.SOP on SOPs PowerPoint Training Presentation and Trainer Instructional Notes

This training tool includes 30 slides on the following subject matter:

➢SOP Definition

➢Role of SOPs

➢Regulatory Requirements

➢Elements of an Effective SOP

➢Useful SOP Tips

➢FDA Inspections and SOPs

16. SOP on SOPs Functional Unit Designations FORM

17. SOP on SOPs Request FORM

18. Standard Operating Procedures for GXP Operations: Practical Applications in FDA-Regulated Industry (Article)

Click here to view complimentary excerpt

This eight (8) page article reviews how SOPs are applied in an FDA-regulated environment. GMP, GCP and GCP SOPs are defined, their regulatory basis, role, which areas they should cover, design requirements, format, document control and process mapping for SOP development are discussed.

GMP SOP CONTENT Power Package is only $159.00