How To Write A Report On A Drug Company

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1 Regulatory Quality Forum October 3 and 10, 2014 Four Points Hotel and Casino, Caguas PR Coming to America: Regulatory Opportunities Business Excellence Consulting, Inc. Phone: eg2 eg3 eg4 eg5 Objectives To point out some findings of our assessments to pharmaceutical companies in Europe who has the intention of distributing their product within USA. Findings based on FDA regulations. 2

2 Slide 2 eg2 eg3 eg4 eg5 Presentaremos observaciones hechas a compaías farmacéuticas de Europa. Son compañías que interesan mercadear su producto a Estados Unidos. Por tanto nuestros ässessments"fueron hechos basandonos en las regulaciones de FDA. Debemos recordar que al no estar bajo las regulaciones de FDA hay observaciones que no se deben penalizar

3 Quality Unit Responsibilities The Quality Unit is not responsible for approving or rejecting lots to the market. This responsibility relies in the General Manager or Production Manager. 3 eg6 Documentation: Procedures Format: Guidelines vs. specific steps Not clear Ambiguous instructions Subject to interpretation/creativity Not followed 4

4 Slide 4 eg6 Errores de documentación fue una situación que observamos a través de todos los documentos.

5 Documentation: Reports Blank spaces Qualification documents Write over Qualification documents Backdating It was no signed at the same time the protocol was executed. Approved by the Quality Unit 5 Method Validation The analytical methods are developed by Analytical Development. This area is not reporting to QA. Personnel do not consider their tasks as part of GMP. 6

6 eg8 Training No awareness of employee training completion. New Employee Orientation: Lack of information Not standardized Not restrictive 7 eg9 eg10 Training Delivery Procedures revisions Evaluations Reading (Lecture) vs. practice vs. classroom 8

7 Slide 7 eg8 Se está implantando sistema computarizado y al momento de entrar datos de adiestramento en el sistema no se garantiza saber cuán adiestrados están los empleados. Nohay manera de saber si los empleados están adiestrados en las últimas revisiones de procedimientos. Slide 8 eg9 eg10 No hay procedimiento de como impartir adiestramiento. Las revisiones no son discutidas con el personal. No se determina cuando un procedimiento debe llevar evaluación

8 eg17 Laboratory System suitability chromatographic analytical methods: no challenge to the efficacy of the column no verification of instrument system suitability performance periodically throughout the chromatographic run Samples, reagents and solutions not properly identified. USP changes 9 Laboratory Instruments qualification: Procedure not clear» Which instruments need to be qualified Primary data» Lack of documentation Change of parameters without Quality Assurance approval eg1 10

9 Slide 9 eg17 problemas de documentación Slide 10 eg1 Durante la ejecución de la Cualificación de Operación (sección 11.2) se cambió el criterio de aceptación de uno de los parámetros. Este cambio se documentó en la sección de comentarios, sin embargo no se consultó al área de Garantía de Calidad previo a la implantación del cambio.

10 eg11 eg12 Stability Pilot lots for registration are being tested by analytical development personnel who do not report to the Quality Unit. Climatic chambers are not properly qualified. 11 Reserve Samples Not all the reserve samples are stored under conditions consistent with product labeling. CFR (3) (b) establishes that An appropriately identified reserve sample of each lot or batch of drug product shall be retained and stored under conditions consistent with product labeling. 12

11 Slide 11 eg11 eg12 Los lotes de registros son analizados porpersonal de desarrollo analítico que no reportan a Quality. Confunden calibración con cualificación

12 Investigations Unclear procedure Follow-up to corrective and preventive actions. QA involvement»classification of deviations»approval or Rejection of product»follow up to due dates 13 Environmental Chemical waste containers were found outside of the waste satellite area. Blisters with and without product were found outside the building. 21 CFR » Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner. 14

13 Environmental Pest control: No insects tramps No proper door seals No insectocuters» CFR , Sanitation Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). 15 eg15 Facilities Cleaning Containers without identification in the hallways Gowning area without identification. Access to gowning area without adequate environmental controls. Dirty hallways. Procedure is not followed.» 21 CFR (a): Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance and proper operations. 16

14 Slide 16 eg15 Existe procedimiento de "gowning"pero no es seguido. Por ejempl, prendas y maquillaje.

15 Incoming of Containers and Closures No representative samples CFR 21, Part 211, Subpart E, Section (b) and Subpart G, Section Containers and Closures» Representative samples of each shipment of each lot shall be collected for testing or examination. Approval/Rejection Based on experience not on specifications» CFR 21 Subpart E section (e) Any lot of such material that does not meet such specifications shall be rejected. 17 Customer Complaints Not handled adequately No formal complaint files Not all complaints are investigated» (2012: 3/138 = 2.17%) (2013: 4/125 =3.2%) Complaints closed by providing replacement product» The goal = contact customer < 24 hrs but without root cause analysis Some investigations performed but not documented. Recalls are avoided: isolated or minimal risk or 18 obvious defect.

16 Change Controls Not established: Document Control: Human dependent processes Research and Development: No documentation to assure repeatability Engineering/Manufacturing: No Engineers available. Technicians/Mechanics make necessary adjustments and changes without considering impact on overall product 19 Change Controls Suppliers No approval/certification process in place No change notification agreement requested for suppliers No consideration of impact of change in suppliers No incoming inspection first order approval based on in process testing 20

17 Thanks!!! 21

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