GMP TRENDS, INC. | Example - Manufacturing Controls


DISTRICT ADDRESS GMP Trends Inc. P.O. Box 8001 Boulder, Colorado 80306			DATE OF ISSUE Introductory
			C.I. ISSUE Issue # MMXIX
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED To: Responsible Person, Director of Quality Assurance
FIRM NAME Pharmaceutical and Related Industries		STREET ADDRESS 5600 Regulation Lane
CITY, STATE AND COUNTRY United States of America and Worldwide		TYPE OF ESTABLISHMENT INSPECTED Pharmaceutical and Related Industries
During a review of inspection reports of U.S. firms (i) (we) observed: EDITED EXCERPTS FROM ACTUAL 483 OBSERVATION REPORTS BY FOOD AND DRUG ADMINISTRATION INVESTIGATORS Manufacturing Controls .....The responsibilities and procedures applicable to the quality control unit (QCU) are not fully followed. Specifically, your quality control unit (QCU) failed to follow SOP ....., Variance Investigation Discrepancy Reports. Some examples include but are not limited to: Section ..... states that trending of variance investigations is performed on a monthly basis via reports and compliance meetings attended by management of multiple departments. However, according to the QA Director your firm does not conduct compliance meetings. In addition, adverse trends and the timeliness of completion of investigations are not identified and evaluated as per the SOP. Section ..... states that the QCU is responsible for evaluating if a discrepancy report requires a variance investigation to be issued. This is not consistently done by QA personnel. Section ..... states that a variance investigation would be opened if the same error is repeated multiple times and not resolved. QA personnel did not consistently follow these instructions. .....Written procedures are inadequate and incomplete. There is no written procedure which addresses the time period before an approved written procedure (SOP, policy document, etc.) is reviewed to assess the need for revision to assure that it both accurately describes current practices and is in compliance with regulations and commitments in applications. Review of SOP ..... “Document Guidelines” finds that this procedure does not address this issue cited in the ..... FDA 483 nor is there another procedure which does. .....Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. Specifically, annual product reviews specified in a written SOP entitled, “Annual Quality Evaluations,” do not include documented summary data, recommendations and quality trends. For example, the firm failed to document the following: Number of accepted and rejected production records reviewed and quality trends. Number of product returns and their types and frequencies and quality trends. Number of deviation reports and associated investigations and quality trends. .....Routine calibration and checking of equipment is not performed according to a written program designed to assure proper performance. Specifically, Equipment Qualification studies performed on the ..... Fluid Bed Dryer do not contain any specifications or verifications of any actual functions that the dryer performs. For example, there were no values obtained to confirm that critical processing step inputs produced expected validated outputs during production, including dryer inlet, exhaust, and product temperatures; pressure differentials, filter pressures, and process step timing. .....Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, as of ....., approximately 448 preventive maintenance tasks remain incomplete and past due. Additionally, the frequency of all tasks for manufacturing and packaging equipment has not been evaluated to ensure preventive maintenance is sufficient.
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Manufacturing Controls

.....The responsibilities and procedures applicable to the quality control unit (QCU) are not fully followed.

.....Written procedures are inadequate and incomplete.

.....Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.

.....Routine calibration and checking of equipment is not performed according to a written program designed to assure proper performance.

.....Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.