Retesting of  Primary Packing Material (PPM)

Retesting of  Primary Packing Material (PPM)

Objective:

  • To lay down the procedure for retesting of primary packaging material (PPM).

Scope:

  •  This SOP is applicable for retesting of primary packaging material in Quality control

Responsibility:

  •  Chemist or above of QC Department for retesting of PPM.
  •  Officer or above of Warehouse Department for giving request for retesting of PPM.

Accountability:

  • Head – Quality Control.
  • Head – Warehouse
  • Head QA- Overall compliance of SOP.

Procedure:

Retesting

  • Approved primary packaging materials due for retesting shall be tested to determine their suitability for use (e.g after for long periods or other condition that might adversely affect the materials).
  • The criteria of first retesting period shall be considered from initial approved date and thereafter based upon previous retest approval date.
  • Retesting can also be carried out as per any directive from Quality assurance department on need basis or risk analysis.
  •  Refer to Annexure II for the retest period schedule for materials under retest.
  •  The list of retest materials shall be shared by warehouse department in advance and shall provide the reanalysis request form for each material as per SOP .
  •  On receipt enter the detail of reanalysis request form in the “Retest Packaging Material Control Register” (Annexure-1) and allot the A.R No. and worksheet.
  •  A.R.No. shall be allotted by adding suffix ‘/ Rn’ to present AR No. where ‘/’ is separator, R is for retesting and n is the number of times retesting is performed.
  •  The QC personnel shall plan and perform the sampling of material under retest as per SOP  and ensure that quarantine label on each container is affixed.
  •  The QC personnel shall ensure that all existing labels (Including quarantine, sampled and approval) on the each container with ‘X ’(CROSS) mark and affix sampled label.
  •  Perform analysis as per the respective packaging material specification and general test procedure or if it is not mentioned complete testing shall be performed as per the respective specification and STP/GTP .
  • The testing and approval or rejection of retest material shall be as per SOP.
  • After complete testing make the released/rejected entry as per annexure No.A01.
  • Affix labels on container in such manner that the word “Quarantine Labels” is completely overlapped.

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List of Annexures / Formats

1 Retesting Packaging Material Control Register – Annexure1
2 Packaing Material Retesting Schedule- Annexure 2

References (If any)

Reason History:

Abbreviation:

  • WH : Ware-House
  • QA : Quality assurance
  • QC : Quality Control
  • SOP : Standard Operating Procedure
  • A.R.No. : Analytical Reference Number
  •  NA : Not Applicable
  •  SG : Sub General
  •  STP : Standard Test Procedure
  •  GTP : General Test Procedure

Annexure1

Retesting Packaging Material Control Register

Retest Packing Material Control Register
Sr. NoDate Name of MaterialManufacturer / Supplier NameGRN No./ DatePrevious A. R.No Retest DateExisting QuantityA.R. No.Worksheet No.

  Quantity      Sampled

Sampled By / DateDate of AnalysisDate of CompletionAnalysed ByStatusRemarks

Annexure 2

Packaing Material Retesting Schedule

Sr .NoMaterial NameRetesting Period Scientific  Rationale
1Rubber Stoppers ( Ready for Sterilization ( RFS) and Non RFS )1 yearBeing elastomeric, the properties can change on storage  conditions for longer period.
2Glass vials / BottlesNA.Resistant to storage for longer

period. Washed and depyrog- enated before use.

3PVC/PVDC  (Poly vinyl chloride, Polyvinyl diene chloride)  PVC/Aclar Film.NA. 

Resistant to storage conditions for longer period. Stored at controlled temperature below 250 C.

4All types of foils (Printed or unprinted) Blister foil, Strip foil, Alu-Alu foil, Plain foil.NA.
5Triple Laminated BagNA.Resistant to storage conditions for longer period. Stored at controlled temperature below 250 C.
6LDPE BagsNA.
7 Desiccants (Silica pouch)NA
8All types of HDPE bottle, Caps, Measuring Cups and DrumsNA.Resistant to storage conditions at longer period.
9Aluminium Seals ( non sterile )NA.
10Aluminium Seals ( sterile )NA.Packed  in intact polybags and resistant to storage conditions at longer

period.

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About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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