STANDARD OPERATING PROCEDURE

SOP No. : Issue Date :

DEPARTMENT
Revision No. : Effective Date :
QUALITY Supersedes No. : R1 Review Date :
ASSURANCE Ref. SOP : Page No. :

TITLE: PRODUCT COMPLAINT HANDLING

PURPOSE
This procedure describes the method for the handling of product complaints so as to
investigate the cause of the complaint & to decide Corrective & preventive actions so as to
avoid future reoccurrence.

SCOPE
This sop is applicable for the handling the complaints of Products manufactured at Leben
Laboratories Pvt. Ltd. Akola.

FREQUENCY
For each Product Complaint

RESPONSIBILITY
Manager QA, Marketing Manager,

PRECAUTIONS
1) Inform Managing Director about the complaint giving complaint details.
2) Complete the procedure & close the complaint within 15 days. In case of
requirement of additional time, Manager QA will get it sanctioned from the
Managing director by mentioning valid reasons.
3) If the complaint indicates adverse drug reaction, comments from the medical
adviser are considered while deciding the corrective & preventive action for the
product complaint.
4) The decision taken respect to corrective & preventive actions must be within the
regulatory norms of the Drugs and Cosmetic Act.

PROCEDURE

1) The complaint from the complainant is received by the marketing department through
oral communication or in written form.
2) According to the complaint received, the marketing dept will record all the required
details in the Product complaint handling form (Format no: FRM-QAD-17) & will
request the complainant for the Complaint Samples.
3) The marketing dept will forward the filled Format, to QA department for further action.
4) On the receipt of the complaint samples, marketing dept will forward them to QA dept
for investigation & analysis. In case if there is some time for the receipt of complaint
samples, the QA dept will start the primary investigation & analysis on the control
sample.
SOP No. : GQA- 27 Page 2 of 3

5) The QA dept will accept the Complaint form, samples & enter all the details of the
form in the Customer complaint handling register (Format No: RG-QA-02). QA
department will assign a unique Identification number to each complaint received.
6) The QA dept will strictly examine the received complaint sample for the conditions of
pack, visual appearance of the contents, evidence of deterioration, any signs of
misuse / mishandling.
7) The QA dept will withdraw Control samples of the complaint batch (es) & will strictly
examine them as per step 6.
8) The QA dept will analyse the complaint sample as well as the control samples for the
tests relevant to the nature of the complaint.
9) When the product defect is discovered in a batch, check the other batches of same
product which might also be affected. The batch in particular which contains
reprocessed product from the complaint batch is used is also taken for investigation.
10) If the complaint is of Toxic or adverse reactions, the samples are sent for the analysis
of relevant biological tests to outside testing laboratory (M/s Beepharmo Labs).
11) All the analytical results of complaint & the control samples are recorded in
PIM/QAD-010/F1
12) After completion of recording of relevant tests, the Manager QA will start for the
investigation. For investigation, Manager QA will consider the views of related HOD’s
&will also cross question the related employees for conclusion of the investigation.
13) Where the investigation reveals specific problems requiring attention in the factory,
Manager QA will convey & impart training on the problem to the concerned
personnel.
14) The investigation details are recorded & based on the investigation, QA manager will
take decision on the Corrective & preventive actions.
15) The decided preventive actions are recorded in the format by the Manager QA.
These actions are discussed & training is imparted to the related personnel & the
HOD & his sign is taken on the format as an acknowledgement.
16) After Investigation, if there is reason to believe that the complaint batch is failing to
meet its specification, the Manager QA will initiate the process of “Product Recall”.
17) Manager QA will record his suggestions in the format which will be referred by the
marketing dept for the closure of the complaint.
18) Referring the suggestions of Manager QA, the marketing dept will take actions
accordingly for the satisfactory closure of the complaint.
19) Based on the investigation, the Manager QA will prepare a reply & will forward it to
the Complainant.
20) The actions taken are recorded in the complaint format & the sign of Marketing
manager & QA manager are taken for the acknowledgement.
21) The details of the complaint are also maintained in the Complaint log register.
22) The QA dept will categorise the complaints as per mentioned below

CATEGORY ‘A’ COMPLAINTS

TABLETS
1. Assay – below 70% for thermolabile products and below 5% of the
permitted limits for thermostable products.
2. Disintegration (except for marginal variation to be viewed on case to
case basis).
3. Dissolution (except for marginal variation to be viewed on case of case
basis)
4. Contamination with foreign matters.
5. Most of the tablets observed in powder form inside the strip pouches.
6. Content uniformity.
7. Additional of permitted colour when not recommended in harmacopoeia.
SOP No. : GQA- 27 Page 3 of 3

CAPSULES
1. Assay – below 70% for thermolabile products and below 5% of the
permitted
limits for thermostable products.
2. Disintegration below 70% (except for marginal variation to be viewed on
case to case basis).
3. Content uniformity.

CATEGORY ‘B’ COMPLAINTS

TABLET
1. Presence of spot / discoloration.
2. Lump formations in few containers due to moisture.
3. Failing in uniformity of weight.
4. Picking.
5. Chipping.
6. Capping.
7. Rough Surfaces.
8. Brittle Tablets.
9. Non uniformity in diameter.
10. Uneven Coating.
11. Non declaration of colour used on the label.
12. Failing in limit test
13. Assay – 70% & above of the label claim for thermolabile products & 5% within
permitted limits for thermostable products.
14. Non content.

CATEGORY ‘C’ DEFECTS

1. Shortages.

DISTRIBUTION LIST

SR.NO DEPARTMENT
1 QUALITY ASSURANCE
2 QUALITY CONTROL

Prepared By Checked By Authorised By Approved By

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