PRINCIPLE
All complaints and other information concerning
potentially defective products must be carefully reviewed according to written
procedures. In order to provide for all contingencies, a system should be
designed to recall, if necessary, promptly and effectively products known or
suspected to be defective from the market.
A product recall is a process of withdrawing one
or more batches or all of a certain product from market distribution. A product
recall is instituted following discovery of a quality defect or if there is a
report of serious adverse reaction of a pharmaceutical product which may cause
health risk.
Total withdrawl of a pharmaceutical product from
market distribution may result in a suspension or discontinuation of
manufacturing of the product.
A returned pharmaceutical product is a finished
product which is already in distribution and returned to the manufacturer due
to complaint of damage, expiration or other reasons such as the condition of
the container or package which may cast doubt on the product identity, quality,
quantity and safety.
COMPLAINTS
A person should be designated responsible for
handling the complaints and deciding the measures to be taken together with
sufficient supporting staff to assist him. If this person is not the head of
Quality Management (Quality Assurance), the latter should be made aware of any
complaint, investigation or recall.
A product complaint and report may be:
a complaint about quality whether physical,
chemical or biological defect of the product or its packaging;
a complaint or report of adverse reaction like
allergy, toxicity, fatal or near fatal reaction and other medical reaction; and
a complaint or report of the product the product
therapeutic activity such as the product lack of efficacy or poor clinical
response.
There should be written procedures describing
investigation, evaluation, appropriate follow-up action, including the need to
consider a recall, in the case of a complaint concerning a possible product
defect.
Each complaint and report should be thoroughly
investigated and evaluated including:
review of all information on the complaint or
report;
inspection or test on the complaint sample
received and if necessary on the retained sample of the same batch; and
review of all data and documentation including
the batch record, distribution record and test report of the product complaint
or report.
The handling of product complaints and reports
including result of their evaluation of investigation and the follow-up actions
taken should be recorded and reported to the relevant management or department.
Special attention should be given to
establishing whether a complaint was caused because of counterfeiting
Any complaint concerning a product defect should
be recorded with all the original details and thoroughly investigated. The head
of Quality Control should normally be involved in the study of such problems.
If a product defect is discovered or suspected
in a batch, consideration should be given to checking other batches in order to
determine whether they are also affected. In particular, other batches which
may contain reworks of the defective batch should be investigated.
A follow up action should be taken after
investigation and evaluating of the product complaint and report. The action
may include:
corrective action where applicable;
recall of the batch or all the finished
products; and
other appropriate action.
Complaints record should be reviewed regularly
for any indication of specific or recurring problems requiring attention and
possibly the recall of marketed products.
The Drug Regulatory Authority (DRA) should be
informed if a manufacturer is considering action following possibly faulty
manufacture, product deterioration, counterfeiting or any other serious quality
problems with a product.
RECALLS
A person should be designated as responsible for
execution and co-ordination of recalls and should be supported by sufficient
staff to handle all the aspects of the recalls with the appropriate degree of
urgency. This responsible person should normally be independent of the sales
and marketing organisation. If this person is not the head of Quality
Management (Quality Assurance), the latter should be made aware of any recall
operation.
There should be established written procedures,
regularly checked and updated when necessary, in order to organise any recall
activity.
Recall operations should be capable of being
initiated promptly and at any time.
Decision for recall a product:
may be initiated by the manufacturing or under
instruction of the government authority;
should come internally from the head of Quality
Management (Quality Assurance) and the company management;
may involve one or more batches or all of the
finished product; and
may result in suspension or discontinuation of
manufacturing of the product.
Institution of Recall
A product recall should be instituted
immediately after discovery of a quality defect or receiving report of adverse
reaction of the product;
Products with high health risk should be
prevented from further usage by having them under embargo as well as recalling
the products immediately. The recall point should reach the consumer level;
The manufacturer documentation system for
product recall should ensure that recall and embargo have been adequate
quickly, effectively and completely carried out; and
Procedure and guideline to recall a product
should be established to enable the recall and embargo be quickly and
effectively carried out from all points of distribution.
The record and report of product recall
including the result of product recall and embargo action should be properly
documented.
All Drug Rregulatory Authority (DRA) of all
countries to which products may have been distributed should be informed
promptly if products are intended to be recalled because they are, or are
suspected of, being defective.
The distribution records should be readily
available to the person(s) responsible for recalls, and should contain
sufficient information on wholesalers and directly supplied customers (with
addresses, phone and/or fax numbers inside and outside working hours, batches
and amounts delivered), including those for exported products and medical
samples.
Recalled products should be identified and
stored separately in a secure area while awaiting a decision on their fate.
The progress of the recall process should be
recorded and a final report issued, including reconciliation between the
delivered and recovered quantities of the products.
The effectiveness of the arrangements for
recalls should be evaluated from time to time.
RETURNED PRODUCTS
The manufacturer should establish a procedure
for holding, investigating and analysing the returned product and deciding
whether the product may be reprocessed or should be destroyed after critical
evaluation is made. Based on the evaluation, the returned products are
categorized as follows:
returned products which still meet their
specifications and therefore may be returned to inventory;
returned products which may be reprocessed; and
returned products which do not meet their
specifications and cannot be reprocessed.
The procedure should include:
identifying and recording the quality of
returned product;
holding the product in quarantine;
investigation, test and analysis of the product
by quality control;
critical evaluation before the management
decides whether the product may be reprocessed or not; and
additional test for a requirement of the
reprocessed product.
Returned products which cannot be reprocessed
should be destroyed. A procedure for destruction of rejected materials or
product should be available. The procedure should include precautionary
measures to prevent pollution of the environment and misuse of the material or
product by unauthorized persons.
DOCUMENTATION
The handling or returned product and the
follow-up actions should be documented and reported. If the product is to be
destroyed, the documentation should include a certificate of destruction which
is dated and signed by the persons performing and witnessing the destruction.
