2-Advantage of complaint management system
3- WHO GMP guideline
4-Classification of quality detection
5-Type of complaints
6-Complaint handling system
7- Records of complaints
- Complaint is define as "The statement that something is wrong or not good enough"
- Handling of complaint is also part of good manufacturing practices
- Consumer expects medicine to be safe and effective but despite best efforts to manufacture good quality products some defective formulation may reach customer
- Tush there should be reliable and effective system in pharmaceutical industry to deal with may any complaint to ensure the safety of customers and if necessary product may be recalled from market.
- Complaint in the case of pharmaceuticals may be related to the quality of product or problems in packaging. Foe example complaint of broken tablets in strips or improper labeling.
WHO GMP Guidelines:
- All compliant related to defective products must be carefully reviewed according to the the written procedures
- There should to designated person (Complaint manager) for handling complaints together with sufficient staff to assist him or her.
- There should be written procedure describing action to be taken including need to consider a recall of product.
- Complaint of defective product should be recorded with all details and thoroughly investigated.
- If product is discovered or suspected in a batch consideration should be give to whether other batches should be checked in order to determine whether they are also effected.
- Whether necessary appropriate follow up action possible including product recall,should be taken after investigation and evaluation of complaint.
- All decision and measures taken as a result of complaint should be recorded.
- Complaint records should be regularly reviewed, for any indication of receiving problems requiring attention.
Classification of quality defects:
(A) Critical Defects: When the type of defects may cause life threatening effect for consumer For example patient receive incorrect product or microbial contamination in sterilized product.
(B) Major Defects: May put the patient at some risk but not life threatening For example contamination is non sterile product may also cause risk to patients.
(C) Minor Defects: These type of defects may cause minor risk to patient For example visible fault in packaging or closures.
(a) Manufacturing defects: Defects due to improper manufacturing.
(b) Design defects: Harm or injury to consumer due to side effects caused due to drugs.
(c) Defective marketing: Inappropriate instruction, recommendation or warnings relating to the usage of products.
Type of product complaint:
(a) Quality complaint: Related to physical chemical or biological properties or may be related to labeling of product
(b) Adverse reaction complaints: May be due any untoward reactions for example allergy reactions.
(c) Other medically related complaints: May be related to improper therapeutic efficacy of product.
Complaint handling system:
Complaint handling in four step:
Step 1: Receiving complaints
Step 2: Technical investigation
Step 3: Corrective action and feedback to customers
Step 4: Monthly report and trend analysis
Step 1: Receiving complaints:
1-Complaint from pharmacist,health practitioners or market received through toll free number, e mails, chat rooms and P.O box.
2-Recording of complaints.
3-Generation of investigation form
a- Data of receipt
b- Basic information about complaints for example name,age,sex,email,phone number etc.
c- Information about concerned product for example batch number, manufacturing and expiry date etc.
d- Details of complaint
e- Amount of product with defect
f- Additional information (If any)
g- Investigation form then send to quality assurance unit for investigation.
Step 2: Technical investigation:
A- Investigation initiated by QA unit
B- Investigation can be divided into two types
(i) Documents based investigation verification of batch records to explain quality deviations.
(ii) Laboratory based investigation
Analysis is performed by QC laboratory using reserve sample representative or retained sample.
There may be three different consequences.
a- Confirmed compliant: Quality problem is identified in sample.
b-Non confirmed complaint: When sample shows complies with specification.
c- Counterfeit/Tamper suspicious: Suspected counterfeit or tampering of product for which complaint is raised. In this case reserve samples qualifies the tests but sample related to complaint fails to match the specification for example difference in packaging of samples from original products or identification of foreign products in samples may be due to counterfeiting or tampering.
After completion of investigation, complaint officer and QA manager must sing the investigation form. Investigation usually completes with in 30 days and complaint file retained for at least 1 year after the expiry of the product.
Step 3: Corrective action and feedback to customers:
A- Corrective action: Corrective action depends on the type and nature of complaint. This may include training to personnel to formal corrective and preventive actions. CAPA action initiated by multidisciplinary team including people from quality control, quality assurance, Regulatory affairs and production. After confirmation by this team regarding quality issues forms the basis of recall of product from the market.
B- Feedback to customers: Respond letter send to complainant including explanation of investigation and details about confirmation of quality defects in product. Company may send free products in replacement of product send by complainant and in this case of non confirmed complaint a scientific information related to proper usage of product may be send with response latter to consumer.
Step 4: Monthly report and trend analysis:
All complaints should be included in monthly reports to perform trend analysis.
Monthly report includes:
Number of complaints received
Number of confirmed complaint
Number of non confirmed complaint
Nature of complaints
Root cause analysis of confirmed complaint.
Report send to departments related to complaints for example QA,QC, Production, management, finance, HR, Regulatory and legal affair.
Records of complaints:
May include following information:
1-Contents of complaints: Name dosage form, type of package, batch number, date, place where complain was raise, cause of complaint, name and address of complainant.
2-Result of investigation: Conditions in which defect is observed, result of investigation, reference sample type and its analysis.
3- Follow up measures: Reply to complaint, remedial action taken, informing serious defects that may rise in the future to competent authorities.