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Issuance and Evaluation of Product Exception Investigation Reports (“EIRs”).

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.
  • 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.
  • Disposition:
  • 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.
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    Date Revision Number Reason for Revision
    00 New SOP

     

Annexure 1

Specimen format of “Exception Investigation Report “

SECTION -I
Exception Date: Due Date:
Product  Name:
Batch No./Lot No            Stage        Mfg. Date Detected  b
Description of the Exception: (Attach separate sheet, if required)

 

 

Officer/In-charge:(Sign. )

Date:

SECTION -II
A.Suspected Root Cause:( Indicate the documents reviewed)

 

Annexure 2

Specimen format of “HOLD” label

H O L D
Product Name:

Batch No.:

Stage

Container No.:

Reason for Hold :

Signature :

Date :

DRL
H O L D
Product Name:

Batch No.:

Stage

Container No.:

Reason for Hold :

Signature :

Date :

Cheminor

Annexure 3

Specimen format of “Exception Investigation Reports ” Register

EXCEPTION INVESTIGATION REPORTS

REGISTER

QUALITY ASSURANCE
S.No.

 

Exception

date

EIR No.

 

Product

 

Batch No.

 

Stage

 

Description

 

Due date

 

Disposition

date

Disposition

 

 

Remarks

 

 

 

 

 

 

 

 

 

 

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