Go to European Union legislation site for pharmaceuticals: HYPERLINK \"http://ec
ID: 51503 • Letter: G
Question
Go to European Union legislation site for pharmaceuticals: HYPERLINK "http://ec.europa.eu/health/documents/eudralex/index_en.htm" http://ec.europa.eu/health/documents/eudralex/index_en.htm
Go to: Volume 4 – Volume 4 contains guidelines for what? How is it different from CFR21 Part211.Go to Part 1, Chapter 2 Personnel
Summarize and highlight the more important points about personnel in the guideline.
Ohm Warning Letter
Go to: HYPERLINK "http://www.fda.gov/default.htm" http://www.fda.gov/default.htm .
In the “Recalls and Alerts” tab, click on “Warning Letters”
Click on “2009”.
Scroll down the table to December 21, 2009. Click on the warning letter for “Ohm Laboratories”.
Discuss cGMP violation no. 3, 5 and 7 regarding personnel cGMP violations.
Explanation / Answer
Volume 4 contains guidelines for what?
Volume -4 contains guidelines for good manufacturing practices for medicinal products for human and veterinary use.
How is it different from CFR21 Part211?
Volume -4 content-The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
CFR21 Part211 content-Fundamental American GMP regulations for pharmaceutical manufacturers.
Summarize and highlight the more important points about personnel in the guideline?
The correct manufacture of medicinal products relies upon people. For this reason there must
be sufficient qualified personnel to carry out all the tasks.All personnel should be aware of the principles of Good Manufacturing Practices.
General Measures:
1.The manufacturer should have an adequate number of personnel with the necessary
qualifications and practical experience. Senior management should determine and provide
adequate and appropriate resources.
2. The manufacturer must have an organisation chart in which the relationships between the
heads of Production, Quality Control and where applicable Head of Quality Assurance or
Quality Unit and the position of the Qualified Person(s) are clearly
shown in the managerial hierarchy.
3. People in responsible positions should have specific duties recorded in written job
descriptions and adequate authority to carry out their responsibilities.
4. Senior management should establish a quality policy that describes the overall
intentions and direction of the company related to quality and should ensure continuing
suitability and effectiveness of the quality management system and GMP compliance through
participation in management review.
Key Personnel:
5. Senior Management should appoint Key Management Personnel.
6. The heads of Production, Quality Control and where relevant, Head of Quality Assurance
or Head of Quality Unit, generally have some shared, or jointly exercised, responsibilities
relating to quality including in particular the design, effective implementation, monitoring and
maintenance of the quality management system.
7. Personnel working in areas where contamination is a hazard, e.g. clean areas or areas
where highly active, toxic, infectious or sensitising materials are handled, should be given
specific training.
8. Visitors or untrained personnel should, preferably, not be taken into the production and
quality control areas. If this is unavoidable, they should be given information in advance,
particularly about personal hygiene and the prescribed protective clothing. They should be
closely supervised.
9. The pharmaceutical quality system and all the measures capable of improving its
understanding and implementation should be fully discussed during the training sessions.
Personnel Hygiene
10. Detailed hygiene programmes should be established and adapted to the different needs
within the factory. They should include procedures relating to the health, hygiene practices
and clothing of personnel.
11. All personnel should receive medical examination upon recruitment. It must be the
manufacturer’s responsibility that there are instructions ensuring that health conditions that
can be of relevance to the quality of products come to the manufacturer’s knowledge.
12. Steps should be taken to ensure as far as is practicable that no person affected by an
infectious disease or having open lesions on the exposed surface of the body is engaged in the
manufacture of medicinal products.
13. Every person entering the manufacturing areas should wear protective garments
appropriate to the operations to be carried out.
14. Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials
or personal medication in the production and storage areas should be prohibited
Consultants
15. Consultants should have adequate education, training, and experience, or any
combination thereof, to advise on the subject for which they are retained.
Discuss cGMP violation no. 3, 5 and 7 regarding personnel cGMP violations?
cGMP violation no. 3- The firm has not established laboratory control mechanisms and documented the execution of laboratory control functions at the time of performance.There has been a failure to document the withdrawal of stability samples at the time of performance, acknowledges that their stability coordinator mistakenly recorded the date of sample. Collection to coincide with the date specified in the stability protocol.ilities were transferred to another employee, we still have concerns regarding your corrective actions. This type of deficiency in CGMP quality system is indicative of the failure by the company's QCD to provide effective training and adequate oversight to assure that no "errors occur.It also implies that the QCD has not established a control system to prevent mixups, to assure the traceability of samples in the laboratory, and to assure the proper storage of samples before testing.
cGMP violation no. 5- The firm has not exercised appropriate controls over computer or related systems to assure that changes in control records or other records are instituted only by authorized personnel. The user account provides full system administrative rights, including editing of the methods and projects. In addition, data security protocols are not established that describe the user's roles and responsibilities in terms of privileges to access, change, modify, create, and delete projects and data. The firm's response to observation 17 in the FDA 483, regarding the failure to establish a procedure that defines the user account responsibilities and privileges and ensures the use of a unique user name and password for each analyst, is also not adequate.
cGMP violation no. 7- The firm has not established an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product. Specifically, the firm does not have an adequate number of personnel to ensure that your firm's manufacturing operations are adequately conducted and completed. For example,
a. The QCU personnel stated that no data back-up of the HPLC Systems has been performed since May 26, 2009 due to insufficient time to perform such activity.
b. Based on stability coordinator's explanation, it is difficult for the coordinator to routinely find the two .employees that are required to open the "vault" to access samples because of a lack of personnel.
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