GMP - Standard Operation Procedure

The purpose of a Standard Operation Procedure is to ensure that all changes related to any aspect of manufacture, testing, holding and distribution are assessed and consequently addressed for their impact on the identity, strength, quality, and purity of the drug product including the assessment of the qualification and validation status and the regulatory situation.

Table of content1. Responsibilities
1.1 Applicant
1.2 System Owner
1.3 Quality Department
2. Purpose / Aim
3. Scope
4. Definitions & Abbreviations
4.1 Like for like replacements / changes
4.2 Temporary and Permanent Changes 54
5. Procedures
5.1 Raising a Change Control Form
5.2 Implementation of Change
5.3 Final Review and Close Out
6. Distribution
Attachment Change Control Form

Deviations (Failure Investigations, Non-Conformances)

The purpose of this procedure is to ensure that all Deviations are: Investigated within 30 working days, all investigations are completely documented, assessed by the responsible line units and QA, corrective actions if applicable are implemented and implementation is tracked, the complete process is managed, monitored and controlled.
. Regulatory Basis, Reference Documents
2. Responsibilities and Accountabilities
3. Purpose / Aim
4. Scope
5. Definitions & Abbreviations
5.1. Deviation
5.2 Incident (minor deviation)
5.3 Investigation
5.4. Immediate Action
5.5. Corrective Actions
5.6. Preventative Action
5.7 Trending
6. Procedure (course of events)
7. Distribution
8. Attachment (form)

Handing of OOS Results
FDA considers the integrity of laboratory testing documentation records to be of fundamental importance during drug manufacturing. As a drug manufacturer you have to assure that your laboratory investigation in cases of failures (OOS results and confirmed OOS results) is done without compromising products quality or current authority expectations. This SOP (13 pages plus attachment) guides you step by step through the process of investigating and documenting OOS results. It describes the responsibilities of laboratory personnel, the QC supervisors and QA Managers. Attached to the SOP is an easy understandable from reflecting the OOS process where you put the relevant data and assessments in three logical sections, the Preliminary Assessment, Investigation Plan and Results and the Final Approval. This SOP only needs little site-specific modification before you can adopt this SOP to your operations.1. Regulatory Basis, Reference Documents
21 CFR 211.165, 21 CFR 211.160, 21 CFR 211.192, FDA Draft
Guideline “Investigating Out of Specification (OOS) Test
Results for Pharmaceutical Production
2. Purpose / Aim
3. Scope
4. Responsibilities and Accountabilities
4.1 ANALYST
4.2 SUPERVISOR
4.3 QUALITY ASSURANCE
5. Procedure
5.1 LABORATORY INVESTIGATION – GUIDING PRINCIPLES
5.1.1 Retesting
5.1.2 Re-sampling
5.1.3 Averaging
5.1.4 Outlier Tests
5.2 CONCLUSION OF THE INVESTIGATION
5.2.1 Interpretation of results
5.2.2 Reporting and Documentation
5.2.2.1 Reporting
5.2.2.2 Documentation
6. Definitions & Abbreviationsdefined.
7. Distribution
8. Attachment (4 pages)
· Section I Preliminary Assessment
· Section II Investigation Plan and Results
· Section III Final Approval


GMP - Standard Operating Procedures


Investigation of Complaints
Insufficient customer complaint handling was and still is one of FDAs top findings in the published warning letters under FDAs Freedom of Information. In addition FDA starts to review not only US related customer complaints for products on the US market but since the New Quality System Approach is used during inspections also complaints for non US – products may be investigated to challenge the companies complaint system. This SOP including a investigation form attached guides you step by step through the process of investigating, documenting, reporting and follow up customer complaints. Also the responsibilities for the complaint investigations are clearly defined, which is a crucial prerequisite for any functional system. This SOP only needs little site-specific modification before you can adopt this SOP to your operations.

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Complaint categories
4.1 Commercial Complaints
4.2 Product Technical Complaints (PTC)
4.3 Adverse Drug Event (ADE) Complaints
5. Responsibilities and Accountabilities
5.1 Quality Assurance
4.1.1 Complaint information
4.1.2 Complaint registration
4.1.3 Internal Notification
4.1.4 Complaint Tracking and follow up
4.1.5 Complaint final decision
4.1.6 Complaint response
4.1.7 Document complaint compiling and retention
4.1.8 Complaint Samples storage and retention
4.1.9 Complaint Trending
5.2 Quality control
5.2.1 Test of complaint samples
5.2.2 Reserve Samples
5.2.3 Report of test results
5. Complaint Investigation
6. Definitions & Abbreviations
7. Distribution
Attachment: Complaint Investigation Form (3 pages)

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