SOP on Complaints
1.0 Objective: This SOP describes a procedure for the investigation of complaints regarding a drug product and remedial measures to be taken
2.0 Scope: This SOP is applicable to all the complaints with respect to drug products manufactured by the company.
3.0 Responsibilities: Quality Assurance Manager to review the complaint, complete the investigations and to conform that remedial measures have been taken to prevent reoccurrence of complaint regarding the said product.
4.0 Materials, Equipment & Documents:
4.1 Records of Production & Packaging of drug.
4.2 Records of distribution of drug.
4.3 Records of Analysis.
4.4 Retention Sample
5.0 Procedure:
5.1 All written or verbal complaints received may be one of the following nature –
5.1.1 Regarding errors in distribution.
5.1.2 Regarding packaging / leakage or breakage problems.
5.1.3 Regarding product quality.
5.1.4 Regarding untoward reaction from product
5.2 Review the records of production & packaging of drug.
5.3 Collect the complete information about the distribution of drug.
5.4 Review the records of analysis of drug.
5.5 Re-examine the retention sample.
6.0 Records: All the complaints except those referring to distribution must be referred to and investigated by the Quality Assurance personnel and records of investigation should be kept along with product complaint records.
Records for product complaint should include –
01. Serial number assigned to the complaint.
02. Name and address of the complainant.
03. Date of complaint.
04. Nature of complaint.
05. If verbal, name of person who received complaint
06. Product name and strength, batch / lot number, batch size, M/D, E/D etc.
07. Size of sample obtained from complainant.
08. Evaluation of complaint
09. Results of examination of retained sample, if examination is done.
10. Action taken by the company.
11. Copy of report made to complainant.
If upon investigations of complaints, any of the following factors is evident, a product recall should be considered –
a. Significant deviation from required potency.
b. Product mix-up during packaging.
c. Misbranding.
d. Product suspected to be toxic.
e. Significant deterioration of the product.