FDA Warning Letters go to Manufacturers in China, Ireland,
Australia and India
In the Month of
May-2018 The US FDA has issued Warning Letters to pharmaceutical firms which
not address cGMP practices
The drug facilities
are:
- Jilin
Shulan Synthetic Pharmaceutical und Nox Bellcow Cosmetics Co, China
- Jalco
Cosmetics, Australia
- Europharma
Concepts, Ireland
- Reine
Lifescience, India.
The five
manufacturers were placed on FDA import alert until the complete correction of
all violations. Here are some of the findings:
Jilin Shulan
Synthetic Pharmaceutical, China
During the four-day
inspection, a number of GMP violations were detected. These included a lack of
documentation for deviations, insufficient data-protection controls as well as
record-keeping delays during manufacturing operations. Especially the integrity
of data and the well-functioning of the quality unit were questioned. It was
found that operators were able to modify and delete files on the firm’s
systems. Therefore, the quality of the manufactured drugs was considered
insufficient. It also appeared evident that the staff had no knowledge of GMP.
Observations:
1. Failure to document
known deviations and out-of-specification results and conduct a thorough
investigation.
2. Failure to exercise
sufficient controls over computerized systems to prevent unauthorized access or
changes to data, and failure to have adequate controls to prevent omission of
data.
3.
Failure to record activities at the time they are performed.
Jalco Cosmetics,
Australia
Observations:
1.
Your firm failed to have, for each batch of drug product, appropriate
laboratory determination of satisfactory conformance to final specifications
for the drug product, including the identity and strength of each active
ingredient, prior to release (21 CFR 211.165(a)).
2.
Your firm failed to test samples of each component for conformity with
all appropriate written specifications for identity, purity, strength, and
quality (21 CFR 211.84(d)(1) & (2)).
3. Your firm failed to establish written
procedures for production and process control designed to assure that the drug
products you manufacture have the identity, strength, quality, and purity they
purport or are represented to possess (21 CFR 211.100(a)).
4. Your firm failed to establish an adequate
written testing program designed to assess the stability characteristics of
drug products. (21 CFR 211.166(a)).
The FDA concludes
that they “recommend a qualified third party to perform a
comprehensive audit of the entire operation for cGMP compliance, including the
quality assurance system, materials system, facility and equipment system,
laboratory system, production system, and packaging and labelling system. CAPA
should then be evaluated by the third party to help ensure systemic remediation
before pursuing resolution of your firm’s compliance status.”
Europharma Concepts, Ireland
Observations:
1.
Your
firm failed to test samples of each component for conformity with all
appropriate written specifications for identity, purity, strength, and quality
(21 CFR 211.84(d)(1) and (2)).
2. Your firm failed to establish adequate written
procedures for production and process control designed to assure that the drug
products you manufacture have the identity, strength, quality, and purity they
purport or are represented to possess, and your firm’s quality control unit did
not review and approve those procedures, including any changes (21 CFR
211.100(a))
Reine Lifescience - India
Observations:
1. Failure to validate
and verify the suitability of analytical methods.
2. Failure to exercise
sufficient controls over computerized systems to prevent unauthorized access or
changes to data, and failure to have adequate controls to prevent omission of
data.
3. Failure to
adequately validate written procedures for the cleaning and maintenance of
equipment
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