FORMAT TO REPORTING AND INVESTIGATION OF QUALITY DEFECTS IN THERAPEUTIC GOODS

HISTORY
This is the first edition of these guidelines.
APPLICATION ----- (Industry Guide)
This is a guide for manufacturers, importers, wholesalers, distributors and retailers.
This guide covers the notification of possible quality defects to the Drug Regulatory Authority of
Pakistan involves the following categories of medicines for humans and veterinarians
use:
• Therapeutic products that are subject to a DRAP registration / enlistment.
• Active substances used in the manufacture of therapeutic products, in case of a
serious or life-threatening situation.
Note: when the defective active substance has been used in the manufacture of finished products
batches of products, already launched on the market, this guidance document is applied, in the usual way
way, for the manufacturer of the finished product.
PURPOSE:
The purpose of the guide is to ensure that stakeholders are better equipped to inform
and investigate quality defects derived from current good manufacturing practices
issues. The general objectives are:
(i) Ensure that possible quality defects are properly investigated and
properly informed within the required deadlines.
(ii) To ensure that the required supervision is applied to defect problems,
corresponding to the level of risk posed to the end user.
DRAP verifies the monitoring of quality defect investigations, to assess the level of
take risks and agree what market actions, if applicable, are necessary to mitigate that risk
and to supervise corrective and preventive actions.
1. QUALITY DEFECTS
A quality defect in a medication can be defined as an attribute of a
medicine or component that may affect the quality, safety and / or
product effectiveness
2. CLASSIFICATION OF QUALITY DEFECTS
Suspicious or confirmed quality defects can be classified into three categories,
according to the risk it represents for the health of the patient or animal.
Critical quality defects are life threatening or could present a serious risk to
health of the patient or animal.
The main quality defects are those that can cause illness or abuse, but they are not
critical.
The lowest quality defects are those that are unlikely to pose a risk to the patient or the animal.
Health.
As a general rule, only minor defects and some major defects can be considered non-reportable.
3. INITIAL RESEARCH PHASE / INFORMATION
MEETING
In many cases, classification, required actions and reporting requirements
associated with a quality defect will be easy to determine immediately, for example, a
obvious quality defect, which is known to affect multiple units or lots. In some cases, these
aspects will not be clear, usually when single or sporadic reports are observed or
Received from the market. It may not be clear if such cases represent a true defect problem or
no. In any case, sufficient information must be collected to confirm:
to. If there is a potential defect (that is, the complaint / report is justified)
yes. If there is a risk to the health of the patient or the animal.
C. When and if the problem needs to be reported to DRAP
re. If any market action is required
There are two phases in the assignment of the above criteria from (b) to (d) to a
default:
(i) Collection of information about the defect and
(ii) Evaluate its possible effects.
3.1. Information gathering
Before assessing the risk associated with a possible quality defect, a higher
The defect must be understood. Information gathering may include
items like:
• Full description of the defect and an examination of samples, if possible
• Correspondence with the people who reported the defect, if applicable
• Review of batch records and any exchange control or deviations associated with the
lot (s)
• Review of previous complaints for the product / lot (s)
The review of previous complaints for the product / lot (s) must disclose the following;
(i) The defect is of an isolated nature and, therefore, it may not be necessary to inform whether the
risk level does not guarantee it, or
(ii) The defect is more widespread in a lot / lots and / or has the
potential to cause shortage or withdrawal from the market; In such cases it must be reported. Full
Knowledge of the extent of a defect in reporting is useful and can
Accelerate the investigation process.
3.2. Risks evaluation
The ICH Q9 guideline on quality risk management (QRM) can be applied in a useful way
for risk assessment and to determine whether a suspicious defect should be reported.
Subsequently or in parallel with the initial investigation methods, the actual risk associated
With the defect itself should be considered. A good collection of information can generate risks
eval