EMA publishes several GMP Non Compliance Reports

The European Database on GMP and GDP Inspections (EudraGMDP) provides a read-only access for industry. The database is a very useful tool to monitor compliance of suppliers and contract partners. It also contains information about inspection findings.

In the field of GMP compliance the Italian Authorithy has issued a GMP non-compliance Report for SRI KRISHNA Pharmaceuticals Ltd., Unit II - A-35, IDA, Nacharam, Hyderabad, Andhra Pradesh, 500 076, India. The company has manufactured non-sterile medicinal products for the European market. In total 10 major GMP deviations were identified during the EU inspection. Again, an Indian company was charged for Data Integrity deviations. The company did not have a proper system in place to make sure that electronic raw data can not be adulterated or deleted.  The inspectors found out that drug products failed to meet established quality control criteria and were not rejected. For example, analysts routinely used the PC administrator password to set the controlling time and date settings back to over-write raw data from sample testing. This practice was performed until "acceptable" results were achieved. In addition Analysts routinely performed what the inspectors called “trial” injections of sample aliquots prior to performing the official/reported analysis. There were no documented sample preparation details for these trial analyses. The results of these trial injections were not reported, and were found to differ significantly from the subsequent reported results.

Sri Krishna Pharmaceuticals had Electronic records in place, but the IT System was not validated to ensure that the records are trustworthy, reliable and generally equivalent to paper records. Even the Master Batch Record had been back-dated by the most responsible persons within the firm’s Quality and Manufacturing departments.

The French Authoritiy issues a GMP non-compliance report for MEDREICH LIMITED – UNIT V Plot n°45 A & B, Anrich Industriel Estate, Bollaram, Medak District, Andra Pradesh, 502325, India. In total 58 deviations from the GMP Guideline were detected. One of the findings was rated critical and 29 were rated major. The company failed to establish appropriate GMP controls for documentation, personal qualification, manufacturing equipment etc. The company produces sterile and non sterile products. According to the French Authority Medreich Limited should not be named on any marketing authorisations whilst this statement remains in place.

A German inspection revealed that Ranbaxy Laboratories Limited, Cephalosporin Blok, Industrial Area No. 3, A.B. Road, Dewas, 455 001, India is not manufacturing according to the GMP requirments. Several sites of Ranbaxy were already found to have serious GMP deviations by US FDA and EU Inspectors. It seems that no quality oversight is in place at Ranbaxy. The manufacturing site has been manufacturing sterile products but entry to the EU market is no longer permitted.

The Spanish authority has issued a GMP non-compliance report for MANUEL RIESGO S.A. Avda. Real de Pinto 142, Madrid, 28021, Spain. The company is a repacker of APIs. The inspection team observed 32 non-conformities to EU GMP Part II. One of these was rated as critical and eight were categorised as major deficiencies. The inspectors found out that the repacker did not have laboratory facilities. Thus it is not possible to ensure that APIs are in compliance to the established standards of quality and purity. No tests to verify the identity of a batch of material were conducted and original manufacturers were not evaluated and approved.

Again a German inspection team issued a GMP non-compliance report for a Chinese API manufacturer. Zhejiang Apeloa Kangyu Bio-Pharmaceutical Co. Ltd., Geshan IndustrialZone, Dongyang, 322109, China. Data Integrity problems are a major concern at this Chinese API manufacturer. The non-compliance report states: "The inspection identified one critical, no major and several minor deficiencies to EU GMP Guide Part II. The critical deficiency was found during inspection of the quality control laboratories. The company failed to establish a procedure to identify and validate GMP-relevant computerized systems in general. Two batch analysis reports for Colistin Sulfate proved to be manipulated. HPLC chromatograms had been copied from previous batches and renamed with different batch and file names. Several electronically stored HPLC runs had not been entered into the equipment logbooks. The nature of these data could not finally be clarified. Neither the individual workstation nor the central server had been adequately protected against uncontrolled deletion or change of data. The transfer of data between workstations and server showed to be incomplete. No audit trail and no consistency checks had been implemented to prevent misuse of data."