ANALYTICAL CHEMISTRY TESTING: Outsourced: Upcoming Projects: Names /Contracts for this area CDA / MSA Audited:

Transcription

1 To better understand your outsourcing needs, please complete the following: COMPANY NAME: Current Customer ( ) DIVISION: Prospect ( ) YOUR NAME: TITLE: ADDRESS: ANALYTICAL CHEMISTRY TESTING: Outsourced: Upcoming Projects: Names /Contracts for this area CDA / MSA Audited: Assays (UV/VIS, IR, AAS) Batch Release Testing (API and Commercial) Chromatographic Tests: (HPLC, GC, IC, ICP-MS) Cleaning Validations / Routine Monitoring / Swabs Disinfectant Efficacy Studies Dissolution Testing USP <232> / <233> and ICH Q3D Elemental Impurities ICH Testing and Storage/ back up systems ICH Stability Testing - Analytical : Appearance, Disintegration, etc. Identification of Impurities Identifications of Active Ingredients CMC Analytical Support - cgmp Compliant data ICH USP Class Elements: Oral, Parenteral, PDE, Inhalation MD/MV: API's, Finished Product, Syringes, Ampoules Method Development / Validation /Remediation OINDP Analytical Testing - only assays (spray patterns) Pharmaceutical Analysis Physical Characterization (ID and Particulate) Chemical Properties: ph, Viscosity, Melting point QC Testing (Product Release) and API Raw Material Testing: Compendial Methods Residual Solvents: (VOC)- Raw Materials, Excipients, Packaging Residual solvents: (OVI) Organic vol impurities Risk Analysis Industrial Hygiene Water Sampling: Pharmaceutical purpose & Protocol Plans

2 To better understand your outsourcing needs, please complete the following: COMPANY NAME: DIVISION: YOUR NAME: TITLE: ADDRESS: MICROBIOLOGY TESTING: Outsourced: Upcoming Projects: Names /Contracts for this area CDA / MSA Audited: Bacterial Endotoxins Test (BET) (USP 85) Kinetic Chromogenic-LAL Chemical Disinfectant and cleaning studies Environmental Monitoring (Plates and contact plates) Microbial contaminant ID Microbial Limits Tests - USP <61> and USP <61/62> Microbiological assessment of antibiotics - (other lab) Mycoplasma Testing Preservatives- Effectiveness Challenge Test: USP 51 (AET) Purified System Water Validations: USP 643/645 Sampling / Analysis /Validation of water (Pharmaceutical) - USP Solvent (Disinfectant) Microbial Attribute Studies: (barrier teeting, packaging, condoms, Medical gloves, hygienic, Particulate Testing - USP 788 CONTAINER CLOSURE AND FUNCTIONALITY TESTS: Glass, Plastic Rubber Closure Injectables: USP <381> Elastomeric Closures Stability Testing: Microbiology - Limits, Endotoxins, Closures Disinfectant Efficacy Studies IN-VIVO AND IN-VITRO Testing: (see page 4) ANTIMICROBIAL CLAIMS: Per FDA, ISO, OECD, ASTM Virucidal Efficacy Claims AND Anti-Viral Claims Topical Antiseptics Ophthalmic / Nasal / Antiviral Drugs / Surgical products i.e. Contact lens-care solutions, medical devices, creams, Blood Glucose Monitoring Devices

3 COMPANY NAME: DIVISION: YOUR NAME: TITLE: ADDRESS: To better understand your outsourcing needs, please complete the following: STABILITY TESTING AND STORAGE: Outsourced: Upcoming Projects: Names /Contracts for this area CDA / MSA Audited: 21 CFR Compliant Stability Testing: Analytical and Microbial Compendial Methods: USP,EP, JP, BBP, FCC, ACS Other Standards, Columns, Raw Data: References and Standards will be provided by: Final Report - Microbac Template( ) Client Template ( ) Tech Transfer - Back to client ( ) Other ( ) CMO Disposal of Samples: TBD Storage and Analysis Protocol Design MICROBAC STABILITY PROGRAM SUPPORT: Climatic Zones (According to ICH and protocols) Comprehensive final reports Controlled 24/7 Monitoring and alert system Development / Validation / Design of Protocol Disaster Plan in place for sample retrieval Long, Intermediate and Accelerated Studies Photo Stability Refrigerators / Freezers / Walk-in Chambers Stability time points confirmed with client Storage Capacity and Monitoring of Samples Stress Tests To better understand your outsourcing needs, please complete the following:

4 In-Vitro Specialty Types and Tests: Methods: In-Vitro specialty Types ad Tests: Methods: Disinfectants/Pesticides/Cosmetics Topical Antiseptics / Medical Devices Disinfectants/Pesticides/Cosmetics Topical Antiseptics / Medical Devices OCULAR: GENOTOXICITY Bovine Cornea Opacity and Permeability (BCOP) OECD 437 AMES Test (ISO ) OECD 471 EpiOcular Eye Irritation (EO) OECD 492 In-Vitro Micronucleus Assay (ISO ) OECD 487 Fluorescein Leakage OECD 460 In-Vitro Mouse Lymphoma Assay (ISO ) OECD 476 Short Time Exposure OECD 491 Chromosome Aberration Assay (ISO ) OECD 473 DERMAL: SPECIALTY ASSAY: EpiDerm Skin Irritation Test OECD 439 MatTek EpiAirway EpiDerm Skin Corrosion Test (SCT) OECD 431 MatTek EpiVaginal Corrositex and Skin Corrosion (EpiDerm) OECD 435 Cytokine Release EpiDerm 3D Tissue MTT Viability Assay 3D SKIN SENSITIZATION: OTHER SPECIALTY STUDY: Direct Peptide Reactivity Assay (DPRA) OECD 442C Material Compatibility 21 CRF KeratinoSens Assay OECD 442D Biocompatibility Testing ISO Human Cell Line Activation Test (H-CLAT) OECD 442E In-Vitro Sensitization Assay in 3D Skin Models VIRAL CLEARANCE STUDY: From beginning to finish PHOTOTOXICITY: 3T3 NRU Phototoxicity OECD 432 1) Risk Assessment of the product regarding viral safety 3D EpiDerm Phototoxicity 2) Selection of target viruses to be tested 3) Selection of process steps to be evaluated for virus elimination CYTOTOXICITY 4) Down scaling the selected manufacturing steps L929 Aga Overlay ISO ) Preliminary studies of cellular toxicity and viral elimination MEM Elution (L929 or MRC-5) ISO ) Viral spiking process runs MTT Cytotoxicity Assay ISO ) Collection and titration of the process samples Direct Contacts Cytotoxicity Assay ISO ) Data generation and calculation of viral clearance factors 3T3 Neutral Red Uptake (NRU) Cytotoxicity Assay 9) Preliminary Reports (2-3) Days 3T3 In Vitro Oral Acute Toxicity Test for LD50 OECD ) Final Report will be written and sent to QA unit for Audit 11) The entire data package will accompany final report

5 REGISTRATIONS/INSPECTIONS: FDA - Registered and Inspected (No #483) July '12 & '15 DEA - Schedule I - V (Federal and North Carolina) ISO/IEC 17025:2005 QUALITY: ISO Specialty Chemistry: Chemical GLP, GCP, GMP Compliant (GXP) Quality Manual Available QMS - International Standard ISO / IEC 17025:2005 (ISO-ILAC-IAF) Expiration 2/28/2019 ACCREDITATIONS / CERTIFICATIONS: ISO/IEC 17025:2005, Chemical Facilities are GMP and GLP Compliant INSTRUMENTS: Chromatography HPLC: PDA, UV, RI, Fluorescence, Conductivity, VIS GC: FID, TCD, ECD, FPD IC: ECD (Ion Chromatography / Elec Chemical) TLC (Thin Layer Chromatography) Spectroscopy LC/MS/MS GC/MS ICP: Detection by MS, OES AAS & GFAA FTIR & UV/Vis 96 Well Plate Reader AUDITS: FDA - July 15, 2015 DEA Pharmaceutical Clients Internal Audits A2LA TESTING IN ACCORDANCE WITH: USP /NF BP, EP, JP ACS/FCC Custom

6 TURN-KEY REGULATORY GUIDANCE: DEVELOPING CLINICAL AND COMMERICAL STRATEGIES VIRTUAL CHIEF MEDICAL OFFICERS AND MEDICAL DEPARTMENT: Microbac has partnered with MedSurg, PI, LLC., - Experienced Physicians and Consultants Comprehensive solutions for drug, biologic and medical device development - Solutions, Strategy and Minimizing Product Risk Developing clinical and commerical strategies designed to maximize safety and ROI throughout the lifecycle of drug development Technical Source for R & D, Medical Affairs, Regulatory Affairs, Quality Assurance, Quality Control, Legal, Customer Service, Production, CMO/CRO Medical Monitoring, Risk Evaluation, and Mitigation Strategy (REMS) Programs for "combination" drugs Auditing Safety Data Pharmacovigilance Plans Adverse Event Program Development and internal response Reducing Product Risk: Human factors, interactions, labeling, indications - R & D, Clinical, and Legal Review CRO: Recovery and Trial Clean Up (Problems and Solutions identified to meet goals and timelines) FDA Interactions and Support / FDA Submissions and Challenges Marketing Material development: Package Inserts, Medical Brochures, (i.e. Benefits vs. Risks) of product Population Health Expert Advice and Analytics: Determining the health outcomes of a group or individuals Investigator initiated trials (sponsor and investigator) In-Licensing and Technology Transfer: Acquisition or Divestment of Products Expertise in Multiple Adverse Event and Concomitant Medication Writing and editing protocols from Phase 1 - Phase IV studies Clinical Trials: Creating, Planning and Guidance (Phase I - IV) - Trial Types: Observational, Investigator Initiated, Comparative Studies Disease States Experience: Analgesic, Cardiovascular, Gastrointestinal, Neurologic, Psychiatric, Pulmonary, oncology, endocrine, anti-infectives Global Experience in Drug and Device Approvals Visit: Articles: MedSurgPI Articles and Presentations: Send your questions to our Doctors: gklein@medsurgpi.com pjohnson@medsurgpi.com

7 AUDIT REVIEW - IN PERSON AND PAPER SOP's Sample Control Quality Assurance Document Control Equipment (Maintenance and Calibration) Facilities: Security Change Control Testing Records Process Control Training (Annual GMP and GLP Training) Electronic Records Control / Back up Computer Systems / Controls / Compliancy / Back Up Test Failures / Out-of-Spec Results Stability Testing Cycles and Test Intervals GAP Analysis and Action Plans for 21CFR Part 11 Compliance Internal Audit Review Customer Service / Technical Sales Manager Roles Call to arrange for a visit.

8

9

10

11