national pharmaceutical control bureau ministry of health, malaysia
DESCRIPTION
SURVEILLANCE OF COSMETICS. National Pharmaceutical Control Bureau Ministry of Health, Malaysia. SURVEILLANCE. Involves Monitoring the SAFETY Checking the QUALITY Ensuring COM PLIANCE to allowable claims, labeling requirements. SURVEILLANCE. JOINT RESPONSIBILITY of the - PowerPoint PPT PresentationTRANSCRIPT
National Pharmaceutical Control Bureau
Ministry of Health, Malaysia
Cosmetic Seminar 2001
SURVEILLANCE
Involves Monitoring the SAFETY Checking the QUALITY Ensuring COMPLIANCE to allowable
claims, labeling requirements
Cosmetic Seminar 2001
SURVEILLANCE
JOINT RESPONSIBILITY of the
Cosmetic industry and
the regulatory authority
to monitor and ensure the
quality and safety of
cosmetics which are
available for sale on the
market
Cosmetic Seminar 2001
SURVEILLANCE
Generally carried out through:
Investigation of product complaints
Monitoring adverse reactions
Selective surveillance of marketed products
Cosmetic Seminar 2001
SURVEILLANCE BY DCA
Unlike the monitoring and surveillance of
pharmaceuticals, the role of the regulatory
authority for cosmetics will be mainly
investigative when an adverse reaction or a
product complaint is received.
Active surveillance will be minimal.
Cosmetic Seminar 2001
Quality & Safety Issues
Ingredients used in cosmetics should be within acceptable levels
Free of all hazardous/ prohibited ingredients
Cosmetics need not be sterile but must
be free of contamination with pathogenic
microorganisms & the density of non-
pathogenic microorganisms must be low
Cosmetic Seminar 2001
Cosmetic Safety
Almost all cosmetics can cause
allergy in certain individuals
Today, serious injury from cosmetics
is a rare event but, it still can happen
USFDA survey - almost 25% of
people questioned had an allergic
reaction to personal care products
Cosmetic Seminar 2001
Safety Issues
Safety of products can be established through
Monitoring of adverse reactions Testing to ensure contents are
within allowable limits and product is free of contaminants
Cosmetic Seminar 2001
COSMETIC SAFETY
Largely dependent on:
Contents
Quality of the finished products
Attitude of the cosmetic industry
Consumer education
Surveillance of Cosmetics
Report received by DCA/industry
Adverse reaction report?
Product defect?
Identify nature of problem
Cosmetic Seminar 2001
Adverse Reactions Monitoring
Consumers will be encouraged to report
adverse reactions through healthprofessionals rather than directly to
theDCA but consumer reports will beentertained for cosmetics
Cosmetic Seminar 2001
Adverse Reactions Monitoring
On receiving an adverse reaction
report, the DCA will need to ascertain
whether it is : an isolated allergic reaction due to the
consumer’s reaction to ingredients in a product, or
a product related problem
Cosmetic Seminar 2001
Adverse Reactions Monitoring
In the case of an allergic reaction
regulators will take note of such
reports
Individual consumers should be
educated to avoid the use of
such products in future.
ADVERSE REACTION REPORT
Isolated Allergic Reaction Cluster of similar reports
Attempt to identifypossible causative agent
Attempt to identifypossible causative agent
Enter into databaseImplement precautionaryaction eg warning labels, restrict usage, withdraw product
Cosmetic Seminar 2001
PRODUCT DEFECTS
Can occur due to Manufacturing problems Transportation Storage
PRODUCT DEFECT
Non- serious/ Minor Product Defect
Serious/ Major Product Defect
Complaint forwarded to registration holder
Investigation conducted by DCA
Industry implement corrective action
Cosmetic Seminar 2001
PRODUCT COMPLAINTS - Role of the DCA
When a product complaint is received by the DCA, nature of the problem will be studied.
Minor product defects - complaint will be channeled to the registration holder for their action
Cosmetic Seminar 2001
PRODUCT COMPLAINTS - Role of the DCA
Serious defects - DCA will conduct its
own investigations which may include
laboratory testing to ensure
compliance to accepted specifications
Products found to be adulterated or
containing prohibited substances may
face deregistration
Cosmetic Seminar 2001
Surveillance by DCA
Sample collection for examination/analysis based on complaints, suspicion
Follow-up on product complaints Random inspection to ensure compliance
to labelling, packaging, etc. Removal of adulterated and misbranded
products from the market
Cosmetic Seminar 2001
Products found not to be in compliance with acceptable standards - DCA may instruct for a product/batch recall to be done within a stipulated time.
Degree and level of recall will depend on the nature and severity of the problem identified.
PRODUCT COMPLAINTS - Role of the DCA
Cosmetic Seminar 2001
FORMS OF PUNITIVE ACTION
If a product is found to contain •adulterants•scheduled poisons•does not comply to limits stipulated in CIR
the DCA can take punitive action such as •instruct a batch/product recall•deregisteration •institute court action with the help of pharmacy
enforcement
Cosmetic Seminar 2001
Surveillance by the Industry
Surveillance of products in the market especially close to “expiry date”
Random inspection of goods received to ensure compliance to labelling, packaging
Customer satisfaction surveys
Cosmetic Seminar 2001
Responsibility of the Industry
The industry should be responsible
enough to impose self-regulation upon
itself and to remove substandard or
defective products as fast as possible
from
the market.
Cosmetic Seminar 2001
PRODUCT RECALLS
Product recalls are actions taken by
the industry to call back products
or batches that present a hazard or
are somehow defective
Cosmetic Seminar 2001
•Degree I : Within 24 hours - usually associated with a serious safety issue
Degree II: Within 72 hours - also associated with a safety issue with a lower risk potential
Degree III: Within 30 days - due to a product defect
DEGREE OF RECALL
Cosmetic Seminar 2001
LEVEL OF RECALL
Level A: Up to consumer level
Level B: Up to distributor level
Level C: Up to wholesaler level
Level D: Up to
manufacturer/importer’s level
DEFECTIVE PRODUCT-risk to consumers
BATCH RECALL PROCEDURE
DECISION TO RECALL**1. Voluntarily by registration holder 2. On DCA’s instruction
REGISTRATION HOLDER PREPARES AND SENDS OUT RECALL LETTERS
Information required:i. Quantity manufactured/ importedii. Quantity soldiii.Quantity in-stockiv. List of purchasers
PREPARE LIST OF NAMES AND ADDRESSES OF WHOLESALERS/
RETAILERS SUPPLIED WITH BATCH UNDER RECALL
EMBARGO UNSOLD STOCKS
SEGREGATE ALL RECALLED STOCKS
DESTROY AFFECTED STOCKS
SEND REPORT TO DCA
ARRANGE TO COLLECT BACK ALL STOCKS UNDER RECALL FROM
WHOLESALERS/ RETAILERS
Cosmetic Seminar 2001
RECORD KEEPING
The DCA will have the authority to check
on investigational methods and recall
procedures
instituted by the industry.
To facilitate this, industry must keep proper
records of all product complaints, adverse
reactions and investigations which were done.
Cosmetic Seminar 2001
SURVEILLANCE -ROLE OF THE INDUSTRY
It would be in the interest of the company
to set up a department to conduct surveillance of marketed products investigate product complaints identify & rectify product shortcomings oversee product recalls
monitor adverse reactions
Cosmetic Seminar 2001
INFORMATION SHARING
ADR
PRODUCT COMPLAINTSREGULATORS INDUSTRY
IMPROVE QUALITY & SAFETY OF MARKETED PRODUCTS
Cosmetic Seminar 2001
CONCLUSION
The registration holder will have theultimate responsibility of ensuring that allcosmetics available for use in the marketare safe for their intended use and meetthe quality standards which are expectedof it.