Prepared By: Mothalia Cheris M.Pharm (Q.A.) Semester-1

Guided By: Mr. Rajesh Parmar

Types of complaints: Three types of of complaints

Quality complaints Adverse reaction complaints Other medically related complaints(1) Quality complaints: Quality

complaints usually originate at consumer level and concern with physical chemical and biological properties or condition of labeling and/or packaging of product.

(2) Adverse reaction complaints: ADR may be allergic reaction or any

other unwanted reaction/fatal reaction/near fatal reaction.

(3) Other medically related complaints: Medically related complaints include complaints such as lack of efficacy or clinical response

A written record should be maintained for all complaints. The Quality complaints should be forwarded to quality control department of the manufacturing unit.

Repots of ADR should be handled by committee of expert in the field. Usually medical advisor of the company is the competent person to handle ADR.

Upon receipt of complaints quality control unit should review all incoming information. If a sample has been received along needed the retained reference sample should be examined and tested. All the relating data and documentation should be reviewed.

When investigation is complete conclusion on the cause and action should be reported to the management.

If it has been found out that the complaint is the result of defective production then a copy of completed report should be sent to production department to take corrective action.

If it has been found that the complaint is result of defective ingredients or packing materials, a copy of report should be send to the purchasing unit for corrective action. It may also be examined whether any other batch should be recalled.

A mention has been made under the WHO GMP text that special attention should be given to establish whether complaint was caused because of counterfeiting.

(i) Contents of complaints

› name, dosage form, package for, batch no;

› date and the place of occurrence of complaint;

› cause of complaint;

› name & address of complaint in detail.

(ii) ) Results of investigations

› Result of investigation regarding market place, circulation condition and condition in which the defect was observed

› Results of investigation of retained reference sample

› Results of investigation of analysis and testing records, Production and storage records

› Results of investigation should be referenced to the BPR of the product

(iii) Evaluation(iv) Follow up measures

› Reply to the complainant› Remedial action so that complaint of this

type do not recur and or drug recall› Competent authorities should be informed

of any serious defect or problem

Objective: Once the quality of a batch of the product is doubtful, it is intended that the product is no more consumed and is recalled for more investigation & decision.

Definition: Removal from the market of specified batches of a product OR May refer to one batch or all batches of product

A person should be designated (authorized person) with responsibility of the execution and Coordination of recalls.

The designated person should be provided with sufficient supporting staff. This person normally should be independent of the sales and marketing.

Complaints and product recall are inter-related. In most of the cases of complaints, it may be necessary to recall the products. The purpose of the drug recall is to ensure that the drug is effectively & rapidly withdrawn from the distribution chain(market).

Determine the degree of recall. There are three degree of recall;

Degree I (product with high health risk requiring freezing of stoke within 24 hours)

Degree II (product with minor health risk or substandard requiring freezing of stock with in 72 hours)

Degree III (product with other reasons for recall).

Disseminate recall instruction with other reasons for recall

Disseminate recall instructions using telephone, telegram. Postage, mass media, ratio TV, depending upon the seriousness of the defect

Freeze the internal stock of the product Establish the record and report of

recalled product Organize the return of the recalled

product

Information/data given below will be useful to perform the recall of drug product:

- Reason for recall; - Details of what is covered by recall and what is

not covered, for example, individual batch or dosage form;

- The nature of risk, if some patients are at risk. Advise as to how they should be managed;

- The cause of defects, if known; - Organization of return of the defective product; - Address, telephone number of persons to be

contacted at national, provincial levels; - Address, Telex and telephone number of radio,

TV, press agencies; - Address, Telex and telephone number of

distributors, wholesalers and hospitals etc.

There should be written procedures for drug product recalls. These procedures should be reviewed and up-dated.

All competent authorities of all those countries to which the suspected product has been distributed, should be informed of any intention to recall the product has been distributed, should be readily available to the person who has been designated to execute and coordinate the recalls.

Progress of recall process should be recorded time to time and subsequently a final report should be issued including reconciliation between the quantities in hand distributed and recovered.

Recalled product should be stored in secured segregated area till its fate is decided. Effectiveness of recall arrangements should be evaluated and changed if need be.

The next question is, what should be done with the recalled product. Or for that matter even the salvaged product ? It will be relevant to recommend certain guidelines for disposal of such product.

Returned and Salvaged Drug Products

A returned drug product is the distributed finished product that has been returned to the manufacturer following complaint. Damage, Expiration of validity or other reasons.

Salvaged drug products is that product which has been subjected to improper storage conditions including extremes of temperature, humidity, smoke, fumes, pressure, radiation due to natural disaster, fire accidents of equipment failure but may be reprocessed or recovered after laboratory validation to meet the approved specifications laid down for that product.

Returned drug products may be classified into :

Drug product that still comply with all acceptable standards according to investigation by quality control unit :

Drug products which can be reprocessed to comply with appropriate specifications :

Unacceptable drug products

Disposition of Returned Drug Products

Procedure mentioned hereunder may be adopted for disposition of returned drug products :

Receiving unit should record amount and identification of returned drug products.

After recording receipt, the receiving unit should hand over the returned drug products to the In charge, warehouse to be placed in quarantine area so that stocks of such product do not get mixed up with trade stocks.

Quality control unit should be informed of the returned drug products which shall examine them and give opinion whether these should be held for possible recovery or should be destroyed.

If recovery is possible, it should be brought to the knowledge of higher management which after considering all the consequences shall give decision whether recovery should be made or not.

Where it is decided to destroy the returned drug products, such products should be destroyed under the supervision of quality control personnel : Destruction should Be carried out in such a way that it does not cause pollution of environment and products do not get into the hands of unauthorized persons.

While disposing off drugs, provisions of Bio-Medical waste (management & Handling) Rules, 1998 may also be referred , if drugs are biological products.

Records of Disposition of Returned Drug Products

Records of disposition of returned drug products should be maintained. These records include records of reprocessing, repackaging and or destruction. Particulars that should be recorded in these records include :› Name of the product;› Batch/lot number› Labeled potency ;› Dosage form ;› Quantity; › Date of receipt ;

› Origin of returned product ;› Storage condition ;› Transportation.

A written recommendation should be issued by quality control unit whether to salvage the returned drug product or destroy it.

Where returned drug product has been recommended to be destroyed, a certificate of destruction should be issued after destruction and should be signed by in charge warehouse and in-charge, quality control. This certificate should form a part of batch documentation

(1) P.P.Sharma “HOW TO PRACTICE GMP”

a Vandana Publications, Fifth Edition.