Issuance and Evaluation of Investigation Reports
- OBJECTIVE :
- To establish a documentation system by which qualified representatives report and investigate the exceptions of drug products in the manufacturing process, in-process specifications.
- RESPONSIBILITY :
- Executive – Production/Packaging to prepare the Exception Investigation Report (EIR).
- Head – Production to investigate and implement necessary corrective actions.
- Head – Research & Development to suggest corrective measures required to avoid recurrence.
- Head – Quality Assurance(QA) to ensure Compliance.
- PROCEDURE :
- Scope of EIR (Exception Investigation Report):
- An exception Investigation Report (EIR) shall be issued in the case of any event detected that may impact on the quality of product. This type of exception requires an investigation by concerned personnel to determine the cause of the event, its impact on the quality of the product, the corrective action to be taken with the involved lot(s)/batch(es) of product(s) and preventive measures required to avoid recurrence. An EIR is not a mechanism for documenting situations caused by normal process variations and/or equipment’s expected performance (such as physical defects, hardness or weight variation etc.,). These situations shall be normally solved by 100% inspections, sorting or removal of affected portions.
- The exceptions could be detected by product analysis/testing, by in-process checks or during a non routine evaluation.
- Situations, which shall need an EIR and Investigation may include the following:
- Manufacturing Operations :
- Failure of batch or significant portion of batch to meet its specifications such as Identification, Dissolution, Content uniformity, Assay, Total impurities and any other requirements.
- Foreign particle contamination, affecting safety, identity, strength, quality, or purity of the drug product
- Processing error or any non-processing error affecting safety, identity, strength, quality, or purity of the drug product
- Equipment failure resulting in failure of batch or significant portion of batch to meet specifications.
- Product Mix-up.
- All others that apply, upon consultation with both Quality Assurance and Research & Development – Heads
- Packaging Operations :
- Product and/or labeling mix-ups.
- Wrong packaging component.
- Error in coding of expiration date and/or batch/lot number.
- All other that apply, upon consultation with both Quality Assurance and R&D – Heads
- Issuance of EIR :
- The person who ever encounters the exception shall immediately stop the process and notify Executive – Production/Packaging in-charge of the Section/ Area about the exception.
- The Executive -Production/Packaging, in-charge of the Section /Area in turn shall notify the Head- Production.
- An EIR shall be prepared by the Executive In-charge of the Section/Area by filling the relevant columns (Except EIR No. and due date) in the Section-I of the EIR (Annexure -1).
- The Executive In-charge of the Section /Area shall immediately identify and quantify the lot under exception and affix a ‘HOLD’ label ( Annexure -2 ) on the portion of the batch/lot processed, and separate the lot.
- The originator of the EIR, in coordination with the Head – Production shall fill the suspected root cause and Extent of exception in Section -II of the EIR .
- Head – Production and Section /Area in charge shall sign the Section -II of the EIR and send it to Executive – QA for allotting EIR No. and due date.
- Executive -QA shall allot number and due date to the EIR, and enter the details of EIR in the ‘EIR s Register’ (Annexure- 3)
- Each EIR shall be allotted a number consisting of nine characters, the first three characters are ‘EIR’ denoting Exception Investigation Report.
- The next three characters are numericals in sequential order starting from 001
- every year.
- The seventh character is a ‘ – ‘
- The last two characters are numericals denoting the year.
- e.g., The first EIR raised in the year 1998 shall be numbered as EIR001-98
- EIR investigation and approval shall be completed within 20 working days. from the date the Exception observed.
- The due date shall be twenty (20) working days from the date on which the exception is observed.
- Executive -QA shall mention the due date on EIR and forward the same to Head – Production for investigation.
- A thorough investigation of the Exception shall be conducted by the affected department. They shall take the help of R&D, QA and Engineering personnel if required.
- The investigation shall extend to determine if there are any other batches involved, with the exception. Document the details of other batches if any, in the EIR.
- Any analytical support if required during the investigation, Executive -QA shall collect sample from the lot under exception and forward the samples to Head -QC for analysis, with a request.
- All the conclusions and results of the investigation shall be documented in Section- III of the EIR. (an additional sheet may be used, if required to mention any supplementary information.) The Head -Production shall sign the Section – III with date.
- Head -Production in co-ordination with Head – R&D shall fill the Corrective action taken, in Section-IV and both shall sign with date.
- Head – Production in consultation with Head – R&D shall fill the suggested corrective action required to avoid recurrence in section – V and both shall sign with date and forward the EIR to Head -QA.
- Head- QA shall review the EIR and suggest the disposition of Material / Product involved. Head-QA shall enter his comments in Section – VI , sign the EIR and forward to Executive officer.
- Executive – QA shall enter the information of EIR in ‘EIRs Register’ ( Annexure-3).
- The Original copy of the completed EIR shall be filed in ‘File for EIRs’ kept in the Documentation Cell.
- In-charge of the Section/ Area shall mention the EIR number as reference at the concerned step, in the BPR where the exception occurred. Executive -QA after completion of EIR shall file a copy alongwith BPR.
- Forms and Records (Annexures)
- Specimen format of “Exception Investigation Report ” – Annexure 1.
- Specimen format of “HOLD” label – Annexure 2.
- Specimen format of “Exception Investigation Reports ” Register – Annexure 3.
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control.engineering
Date Revision Number Reason for Revision – 00 New SOP
Specimen format of “Exception Investigation Report “
|Exception Date:||Due Date:|
|Batch No./Lot No||Stage||Mfg. Date||Detected b|
|Description of the Exception: (Attach separate sheet, if required)
|A.Suspected Root Cause:( Indicate the documents reviewed)
Specimen format of “HOLD” label
|H O L D|
Reason for Hold :
|H O L D|
Reason for Hold :
Specimen format of “Exception Investigation Reports ” Register
EXCEPTION INVESTIGATION REPORTS
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