Unit:4 Complaints Pharmaceutical Quality Assurance

 

In the revised schedule M this element appears under the title of “Complaints and adverse reactions”. Guidelines recommended that a person (Quality control) should be designated for handling of complaints and to decide the measures to be taken. Guidelines also recommend SOP for complaint handling.

Objective- Objective of the guidelines under this element is that defective product is immediately recalled, matter is investigated and remedial measures are taken.

Complaints may be of three types-

1.    Quality Complaints- it usually originates at consumer level and concern with physical, chemical and biological properties or condition of labeling and/or packaging of the product.
2. Adverse reaction complaints (ADR)- ADR may be allergic reactions or any other untoward reactions or fatal reaction or near fatal reaction.
3. Other medical related complaints- it includes complaints such as lack of efficacy or clinical response.

 All verbal or written complaints or reports received by the manufacturer are complaints.

Handling of Complaints

A written record should be maintained for all complaints.

• The quality complaints should be forwarded to the quality control department of the manufacturing unit.
•   Reports of the adverse reaction should be handled by a committee of experts in the field. Incharge of the quality control unit should be a member of this committee. Usually a medical advisor of the company is the competent person to handle ADR.

Upon receipt of the complaints, quality control unit should review all the incoming information. If sample has been received along with complaint, the sample should be examined and tested. If needed, retained reference samples should be examined, tested/analyzed. All the related 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 that the complaint is the result of defective production then a copy of the completed report should be sent to the production department to take corrective action.

If the formulation or process of manufacture is required to be amended, master formulation record should be amended accordingly and should be authorized. If it is found in the investigation that complaint is result of defective ingredient or packaging materials, a copy of report should be sent to the purchasing unit for corrective action. It may also be examined whether any other batch (s) should be recalled.

It is responsibility of the quality control incharge to see that each complaint is recorded, evaluated and reported to the management. Records of complaints should include the following information:

1. Content of the complaint                                                                                                                    -Name, dosage form, batch no                                                                                                    - Date and place of occurrence of complain                                                                                        -Cause of complain.                                                                                                                            - Name and address of complaint in detail.
2.  results of the investigations should include                                                                                         -Results of investigation regarding market place, circulation condition and condition in which the defect was observed                                                                                                                      -Results of investigation of retained reference sample                                                                       -  Results of the investigation of analysis and testing records, production and storage records           -  Results of investigation should be referred to the BPR of the product
3. Evaluation
4.   Follow up measures include                                                                                                     - Reply to the complaint                                                                                                                   --Remedial action so that complaints of this type do no recur and/or drug recall.             - Competent authorities should be informed of any serious defect or problem.

Product Recalls

It has been stated that there shall be written procedures describing action to be taken, recall to be made of the defective product. Guidelines recommended that a person should be designated (authorized person) with responsibility of execution and coordination of recalls. The designated person should provide sufficient staff. This person normally should be independent of sales and marketing.

Objective- once the quality of a batch of the product is prima facie doubtful, it is intended that the product is no more consumed and is recalled for more investigation and decision.

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

Product Recall procedure 

1. 1.      Determine the degree of recall. There are three degrees of recall                                                     -Degree I –product with high health risk requiring freezing of stock within 24 hours            - Degree II- product with minor health risk or substandard requiring freezing of stock within 72 hours                                                                                                                                                    -  Degree III- product with other reasons of recall.
2.  Disseminate recall instructions using mobile, telephone, telegram, postage, mass media, radio, TV, depending upon the seriousness of the defect.
3.  Freeze the internal stock of the product
4.   Establish the record and report of recalled product.
5.  Organize the return of the recall product.

Progress of recall procedure 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 products should be stored in secured segregated area till its fate is decided. Effectiveness of recall arrangements should be evaluated and changed if needed. It will be relevant to recommend certain guidelines for disposal of such products.

 

Returned and Salvaged drug products

A returned drug product is the distributed finished product that has been returned to the manufacture following complaint, damage, and expiration of validity or other reasons. Returned goods can be classified into

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

-          Drug product which can be reprocessed to comply with appropriate specifications

-          Unacceptable drug products.

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 or equipment failure but may be reprocessed or recovered after laboratory validation to meet the approved specifications laid down for that product.

Disposition of Returned Drug Products

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

1.  Receiving unit should record amount and identification of returned drug products.
2. After recording receipt, the receiving unit should hand over the returned drug products to the incharge, warehouse to be placed in quarantine area so that stocks of such products do not get mix up with trade stocks.
3. 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.
4. 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.
5. Where it is decided to destroy the returned drug products, each product 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.

Records of Disposition of Returned Drug Products

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 no

-          Labeled potency

-          Dosage form

-          Quantity

-          Date of receipt

-          Origin of returned products

-          Storage conditions

-          Transportation

A written recommendation should be received from quality control unit whether to salvaged the returned drug products or destroy it. Where a returned drug product has been recommended to destroy, a certificate of destruction should be issued after destruction and should be signed by incharge of warehouse and incharge of quality control. This certificate should form a part of batch documentation.