FDA 483 TRIAD GROUP OBSERVATIONS (H & P Industries) 11/29/10 -01/07/11

FDA 483 TRIAD GROUP OBSERVATIONS (H & P Industries) 11/29/10 -01/07/11

Comment

Enclosed are three of the forty six Observations along with commentary from the 30 page Triad Group FDA 483.  These three Observations focus upon the training and education within the Triad Group as noted by the FDA during their investigation.  It should be observed within these Observations that the FDA has noted that individuals performing various tasks should possess the various skill sets necessary to perform their functions.  The FDA questions the ability of a chemist who has limited microbiological skills to provide training to personnel. 

OBSERVATION 13

Individuals responsible for supervising the processing and holding of a drug product lack the education to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess. 

Specifically, the individual responsible for providing training to the Microbiological Laboratory personnel is a Chemist with limited background in Microbiology. 

OBSERVATION 14  

Employees engaged in the processing and holding of a drug product lack the education required to perform their assigned functions. 

a) Employees performing the Microbiological testing of finished products and process water used to manufacture products and clean equipment do not have an education in Microbiology. 

b) There is no one currently employed that has the education in the engineering field to design equipment for the production of pharmaceutical products, i.e., alcohol swabstick production lines have (b)(4) after the product contact area, non-cleanable product contact surfaces on numerous pieces of equipment, lack of a preventative maintenance schedule for the compressed air system, lack of routine preventative maintenance of the (b)(4) in the Deionized Water system. 

OBSERVATION 15  

Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations. 

Specifically:

a) Temporary employees are given cGMP training by the temporary agency that employs them; they do not receive any additional training at this company such as job specific training. In addition, cGMP training is not provided on a routine basis. For example:

1) Operator (b)(6) a temporary employee, received training from the temporary agency on 7/28/09 and started at this company on 7/29/09. Training since that time has included line clearance, raw data integrity and 10-up monthly maintenance.

2) Temporary employee (b)(6)  received training from the temporary agency on 8/4/08 and started at this company on 8/5/08; he hasn’t received cGMP training since then.

3) Temporary employee (b)(6) received training from the temporary agency on 11/13/09 and started at this company on 9/14/09; he hasn’t received cGMP training since then. 

b) On 12/2/l 0 an employee was observed to(b)(4)  of the master batch formula and mixing instruction for batch OM100B. This step involved a(b)(4)  of the batch. The employee completed the check, but there was not a second employee to verify the step. The operator explained the second employee that verifies this step in the b)(4) was busy. The operator would tell the second employee the check had been completed and the second operator would sign the “verified by” place in the record.

c) The analysts performing the microbial out of specification investigation had never been trained on the procedure SOP-LAB-002-00 00 “Microbiological Out of Specification (OOS) Investigations” effective 10/28/10.  Comment  The FDA has frequently cited within Warning Letters that microbiologists are present within a Company and available to both provide microbiological functions and to train others in this area (see Chiron Warning Letter 2004).  Please also review the section below from 21 CFR Part 211.    Sec. 211.25 Personnel qualifications.

 

(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.