STANDARD OPERATING PROCEDURE

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1 STANDARD OPERATING PROCEDURE Title: Discrepancy Report Procedure Effective Date: Approvals (Signature and Date): Responsible Department Head Technical Authority QA/QC 1. PURPOSE 1.1 To describe a method for identifying, documenting and resolving discrepancies, such as: Planned and unplanned process or testing deviations, including those related to approved procedures and methods, equipment, and facilities Non-conforming parts, sub-assemblies, or finished products Environmental monitoring results for air, water, or surface exceeding alert or action levels. 1.2 To establish an effective corrective action program that includes: 2. SCOPE The investigation and identification of causes for discrepancy occurrences Elimination of causes for existing undesirable conditions to prevent or minimize future discrepancies. 2.1 This procedure applies to discrepancies involving incoming raw materials, in-process sub-assembly, unreleased finished product, utilities and equipment. 3. RESPONSIBILITY 3.1 Manufacturing personnel are responsible for: Obtaining approval for all planned manufacturing related discrepancies prior to implementation Recording all unplanned discrepancies that occur during manufacturing operations Notifying the affected area supervisors of discrepancies. 3.2 Facilities personnel are responsible for: Obtaining approval for all planned facilities related discrepancies prior to implementation Recording all unplanned discrepancies that occur during operation of systems and utilities that serve facilities used for the manufacture, testing, or storage of incoming raw materials, inprocess sub-assemblies, or finished products Notifying affected area supervisors of discrepancies. 3.3 Quality Control personnel are responsible for: Obtaining approval for all planned testing/inspection discrepancies prior to implementation Recording all discrepancies that occur during testing/inspection or during environmental monitoring. All proprietary rights reserved. Page 1 of 13

2 3.3.3 Notifying assigned area supervisors of discrepancies 3.4 Area supervisors are responsible for: Investigating the cause of discrepancies within their area Evaluating the potential impact of discrepancies on the process or product Recommending appropriate corrective action and assuring the corrective action is implemented in a timely fashion. 3.5 Quality Assurance is responsible for: Determining the impact discrepancies have on product quality Determining action taken for discrepant material (i.e., proceed as scheduled, hold product for additional testing, conduct MRB meeting) Closing out Discrepancy Reports by verifying the implemented corrective action satisfies the requirements of the corrective action identified on an approved Discrepancy Report. 3.6 Management is responsible for the: Review and approval of Discrepancy Reports Assignment of resources to support identified corrective actions Review of discrepancy summary and trend analysis reports for trends, recurring discrepancies, and effectiveness of corrective actions. 3.7 Quality Assurance and Document Control are responsible for the administrative activities of the discrepancy reporting system, including: Periodic follow-up to assure timely completion of corrective actions identified in Discrepancy Reports Generation of summary and trend analysis reports Retention of all records and reports required by the Discrepancy Report System. 4. REFERENCES AND APPLICABLE DOCUMENTS SOP-1.0 Document Change Control SOP-1.0 Customer Complaint Procedure SOP-1.0 Material Review Board SOP-1.0 QC Test Failure, Repetition Rules and Investigation SOP-1.0 Quality Improvement Project Monitoring System 4.6 Company Quality Manual for applicable regulatory references. 5. MATERIALS AND EQUIPMENT 5.1 None All proprietary rights reserved. Page 2 of 13

3 6. HEALTH AND SAFETY CONSIDERATIONS 6.1 None 7. DOCUMENTATION REQUIREMENTS 7.1 Discrepancy Report form - Attachment A This form is two pages, stapled together by Document Control, and must be completed for every discrepancy not relating to an environmental monitoring result. 7.2 Environmental Monitoring Discrepancy Report form - Attachment B This form is two pages stapled together by Document Control, and must be completed for every environmental monitoring result discrepancy. 7.3 Notice of Discrepancy Report Cancellation - Attachment C 7.4 Discrepancy Report Logbook A Discrepancy Report Logbook that tracks Discrepancy Report numbers and relevant information will be maintained by Document Control. The logbook must include areas to record the sequential number, the date of the discrepancy, the product Part Number and Lot Number, the procedure document number, the equipment or system number, the discrepancy description, the originator s initials, the initials of the person responsible for the corrective action, the corrective action due date, and the Discrepancy Report closure date. The information in the logbook is maintained in a Microsoft Excel and is updated periodically by Document Control. After each update, a hard copy of the information is printed and inserted into the Discrepancy Report Logbook. 7.5 Discrepancy Report Binder A Discrepancy Report Binder will be maintained in Document Control that contains all open Discrepancy Reports filed according to the Discrepancy Report number. 7.6 Discrepancy Report File 8. DEFINITIONS A Discrepancy Report File will be maintained in Document Control that contains all closed Discrepancy Reports filed according to the Discrepancy Report number. 8.1 Discrepancy types: Planned Discrepancy: A decision made prior to the time of an operation to deviate from an established schedule, plan, or approved process or procedure, including manufacturing, facility, and testing/inspection procedures. Prior to the implementation of any planned discrepancy, approval must be obtained as required in Section Unplanned Discrepancy: A deviation from an established schedule, plan, or approved process or procedure, including manufacturing and testing/inspection procedures, discovered during or after an operation was performed. Unplanned discrepancies include equipment or utility failures in facilities used for the manufacture, testing, or storage of incoming raw materials, inprocess sub-assemblies, or finished products. All environmental monitoring discrepancies are classified as unplanned Non-Conformance Discrepancy: A failure of a raw material, in-process sub-assembly, finished product, or stability sample to meet an approved specification. In the case of a discrepancy during QC testing, the non-conformance must be caused by the material and not by sample preparation, equipment malfunction, operator error, or any other identifiable cause as defined in SOP-1.0. Re-testing to confirm the non-conformance of the material All proprietary rights reserved. Page 3 of 13

4 may be performed as described in SOP-1.0. Failures related to released finished product for distribution identified by customers are addressed by SOP-1.0. Nonconforming material where the testing and specifications are valid require a Material Review Board (MRB) to determine disposition. Visually detected non-conformances found during either receiving inspection or in-process inspection may be sorted to remove the discrepant parts then accepted prior to MRB review. 8.2 Discrepancy causes (Note: Cause category number 8 is omitted): 9. PROCEDURE Material (1): A non-conformance discrepancy where the testing and specifications are valid Method (2): A discrepancy caused by method or procedure not yielding the specified result, including those due to inadequate equipment or procedure validation/qualification (equipment or procedures found inadequate or unsuitable for its intended use), inadequate test method validation, or the establishment of specifications without adequate supporting data Document (3): This category is reserved for Trial Use documents or red-lined documents (changes to approved documents) that are used in place of approved procedures Operator (4): A discrepancy caused by an error made by an employee or caused by insufficient training Equipment (5): A discrepancy caused by equipment, system or utility failure Environment (6): A discrepancy caused by an air, surface, or water monitoring result (including HVAC operating specifications) that exceeds alert or actions levels Schedule (7): A planned discrepancy caused by deviations from established schedules or testing plans. Established schedules include environmental monitoring, preventive maintenance, and calibration programs. Deviations from testing plans include the use of a material before release testing is completed Vendor (9): A discrepancy caused by the performance of a vendor (not including supplying materials that do not meet their specifications). Examples include changes to vendor documentation (vendor/catalog part number or certification), packaging changes that are not communicated prior to production, missing vendor documentation, and shipment errors. Contract test lab errors are also included in this category Other (10): Where the cause can not be determined or more appropriately belongs in separate category not listed Initiating a Discrepancy Report Any employee identifying a discrepancy must either initiate a Discrepancy Report (DR) or notify the area supervisor immediately of the occurrence. Personnel who initiate a DR complete the Originator section of the appropriate DR form (Attachment A or B) and forward it to the area supervisor where the discrepancy occurred for evaluation. 9.2 Originator The originator determines the type of discrepancy and completes the first portion of the DR, providing product, document, and equipment or system details as necessary. The originator provides a clear, concise description of the discrepancy along with other relevant information such as the step in the Manufacturing Batch Record (MBR) affected by the discrepancy, the time or duration of equipment failures, or any remedial action taken as a result of the discrepancy. All comments must be objective and without making conclusions as to the cause or impact of the discrepancy. The originator signs the DR and then forwards it the area supervisor. All proprietary rights reserved. Page 4 of 13

5 9.2.1 Environmental discrepancies: The originator indicates whether the discrepancy was related to routine environmental monitoring or environmental monitoring during aseptic processing, the test method, the test results, and the approved alert and action levels. The originator also provides an assignable cause if it is apparent by review of the data Release of sub-assemblies: If the production schedule requires a quarantined sub-assembly or raw material to be used in manufacturing prior to approval by QA, then a planned DR is initiated with the appropriate information provided, including the part and lot numbers of every sub-assembly and finished product intended to be manufactured with the quarantined material. A copy of the DR is placed in every affected Lot History File. Finished product will not be released until every quarantined sub-assembly and raw material used to manufactured the finished product has been approved. No quarantined finished product will be released for distribution until all testing is complete and it is approved by QA. 9.3 Area Supervisor The area supervisor is responsible for determining the cause and impact of the discrepancy, and for recommending appropriate corrective action to prevent further occurrences. After completing the required sections, the area supervisor forwards the DR to Quality Assurance Discrepancy Investigation/Cause The supervisor, in consultation with the originator and other personnel as necessary, investigates the cause of the discrepancy and completes the appropriate sections of the DR. If the cause cannot be readily determined, the supervisor may enter unknown for the cause; in these cases, either Quality Assurance or the management personnel responsible for approving the DR may require further investigation to determine the cause prior to approval Anticipated Process/Product Impact The supervisor evaluates the impact the discrepancy may have on the process or product. The information in this section will assist Quality Assurance to determine product quality implications and management personnel to assess the significance of the discrepancy. If necessary, the appropriate technical authorities, such as Development or Engineering, will assist in evaluating the impact of the discrepancy. Enough technical information, including references to development reports or validation documents, should be provided to support any conclusion concerning product or process impact Corrective Action 9.4 Quality Assurance The corrective action must be specific and verifiable to prevent the future occurrence of a discrepancy for the same or similar reason. If corrective action is not yet apparent, the supervisor may request further investigation or an MRB to determine the appropriate corrective action. Corrective Action is assigned to an individual who has knowledge and experience with the subject of the discrepancy (i.e., product, process, equipment, system, area). The acceptance of responsibility for the corrective action is indicated by obtaining the signature of the assigned individual. The assigned individual shows commitment to timely completion of the corrective action by recording a target due date. The corrective action may be assigned to a Quality Improvement Project (QIP) according to SOP-1.0. QA reviews the information on the DR and determines the cause category of the discrepancy. Additionally, QA determines the impact the discrepancy has on product quality and recommends the disposition. QA assigns a sequential number to the report and enters the required information into the Discrepancy Report Logbook. A copy is placed in the Discrepancy Report Notebook while the DR is routing for review and approval. All proprietary rights reserved. Page 5 of 13

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