GMP TRENDS, INC. | Example - Packaging & Labeling 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 Packaging & Labeling Controls .....Containers and closures are not tested for conformance with all appropriate written procedures. Specifically, the firm failed to follow SOP ..... entitled, “Receiving Containers & Closures.” For example, there is no documentation in the Receiving Log for Containers regarding the examination of molding for uniformity, testing of the threads, and other container defects. .....Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, incorporation of new products into the Cleaning Validation Matrix did not occur according to a written procedure designed to assess the fit of such new products into the existing matrix. Additionally, there was no evidence of cleaning verification post cleaning. For example, ..... products were added to packaging (filling) operations without data to support the assessment of fit of these products into the existing cleaning matrix. .....Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit. Specifically, the set parameters, including the scan time, of the ..... filling machine used during the packaging of your ….. products, packaged in bottles, were changed from the approved and validated settings. These changes were not documented, reviewed, or approved by the quality control unit, as required by your firm’s procedures. For example: The validated scan time for the ..... filler for the packaging of ..... into 38 and 44 count bottles is ..... On ....., the observed settings were as follows: ..... Your firm has no documentation of the change being approved. Your firm could not determine who made the change, why the change was made, or how many changes have been made since the validation of the system was conducted on ..... .....Batch production and control records do not include in-process results for each batch of drug product produced. Specifically, results of the in-process inspections performed by the packaging operators on the packaged products are not documented. There are also no limits established for these in-process inspections to ensure that the process and/or production equipment are maintained in a state of control. In addition, there was no formalized/approved procedure to describe these in-process inspections. .....Investigations of a failure did not extent to other drug products that may have been associated with the specific failure or discrepancy. Specifically, the firm’s investigation into the rejection of ..... blister cards, for leak test failures, was not extended to other drug products processed on the same equipment, despite their conclusion that equipment failure caused the product defect. .....Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, there is no documentation of the adequacy of containers used to ship bulk ..... capsules for final packaging or to store retain samples. On at least one occasion, failing assay results obtained from retain samples 10 months post manufacturing were discounted because packaged product tested by the repacker had passing results. Reportedly no stability testing has been done either by Firm or by the Application Holder for product in bulk shippers, and none has been done by the Firm for retain samples.
SEE REVERSE OF THIS PAGE	EMPLOYEE(S) SIGNATURE GMP TRENDS INC.	EMPLOYEE(S) TITLE Editor	DATE ISSUED Introductory

FORM GMP VOLUME I SUPPLEMENTS PREVIOUS EDITIONS

INSPECTION OBSERVATIONS

GMP TRENDS®, INC. edits and publishes this information dissemination report semi-monthly for quality-minded executives in the pharmaceutical and related industries. Subscription rates: $480 per year; additional copies $240 per year when mailed in the same envelope with regular subscription copy. Add $45 for delivery outside of the USA and Canada. Also available online. For details visit www.gmptrends.com

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Packaging & Labeling Controls

.....Containers and closures are not tested for conformance with all appropriate written procedures.

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

.....Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.

.....Batch production and control records do not include in-process results for each batch of drug product produced.

.....Investigations of a failure did not extent to other drug products that may have been associated with the specific failure or discrepancy.

.....Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.