FDA Warns Drug Facilities in China, Ireland, Australia and India

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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