1331 Pine Trail

Tomball TX 77375

202-982-3002

Info@consultareinc.com

ALL INCLUSIVE SERVICES

Pharmaceuticals Regulatory, Accreditation, Certification, and Compliance Management Services

Design to support your regulatory, accreditation, and certification compliance.

Introduction video

Compliance Services

REGULATORY

21 CFR Part 211 – cGMP for Finished Pharmaceuticals

  • General Provisions
  • Organizational
  • Personnel
  • Building
  • Facilities
  • Equipment
  • Control of Components
  • Drug Product Containers
  • Closures
  • Production
  • Process Controls
  • Packaging
  • Labeling Control
  • Holding
  • Distribution
  • Laboratory Controls
  • Records
  • Reports
  • Returned and Salvaged Drug Products

STANDARDS

General Provisions
  • Scope
  • Definitions
Organizational and Personnel
  • Quality Control Responsibilities
  • Personnel Qualifications
  • Personnel Responsibilities
  • Consultants
Holding and Distribution
  • Warehousing Procedures
  • Distribution Procedures
Building and Facilities
  • Design
  • Construction
  • Lighting
  • Ventilation
  • Air Filtration
  • Air Heating and Cooling
  • Plumbing
  • Sewage and Refuse
  • Washing
  • Toilet Facilities
  • Sanitation
  • Maintenance.
Equipment
  • Design
  • Size
  • Location
  • Construction
  • Cleaning
  • Maintenance
  • Automatic
  • Mechanical
  • Electronic
  • Filters
Components, Containers & Closure
  • General Requirements
  • Receipt
  • Storage
  • Testing
  • Approval
  • Rejection
  • Retesting
  • Rejected
  • Drug Product Containers and Closures
Production and Process Controls
  • Written Procedures
  • Deviations
  • Components Charge-In
  • Yield Calculation
  • Equipment Identification
  • Sampling
  • Testing
  • In-Process Materials
  • Drug Products
  • Production Time Limitations
  • Microbiological
  • Reprocessing
Packaging & Labeling Control
  • Materials Examination
  • Usage Criteria
  • Labeling Issuance
  • Packaging and Labeling Operations
  • Temper-Evident Packaging Requirements
  • Over the Counter
  • Human Drug products
  • Drug Product Inspection
  • Expiration Dating
Laboratory Controls
  • General Requirements
  • Testing and Release for Distribution
  • Stability Testing
  • Special Testing Requirements
  • Reserve Samples
  • Laboratory Animals
  • Penicillin Contamination
Records and Reports
  • General Requirements
  • Equipment Cleaning and Use Log
  • Component, Drug Product Container, Closure, and Labeling Records
  • Master Production and Control Records
  • Production Record Review
  • Lab Records
  • Distribution Records
  • Complaint Files
Returned and Salvaged Drug Products
  • Returned Drug Products
  • Drug Product Salvaging

ACCREDITATION & CERTIFICATION

  • ANAB and ANSI Accreditation
  • ASQ Certification Standards
  • Good Manufacturing Practices
  • HACCP Certification
  • ISO International Standards
  • National Brand Certification Program
  • Natural Product Association Certification Program
  • Retail Certification Program
  • UL Standards

SOFTWARE, IT, & COMPLIANCE PROGRAMS

PRP

Prerequisite Programs

ETRR

Employee Training Requirements and Records

RVVMP

Records Verification and Validation Management Program

CAMP

Corrective Action Management Program

PMP

Preventive Maintenance Program

QCMS

Quality Care Management Program

CCMS

Customer Care Management Program

SOP Pro

(PFL) Programs, Policies, Procedures, Forms for Records, Lessons for Training.

PMS

Project Management System

ICMS

Inventory Control Management System

IAMP

Internal Audit Management Program

SAMP

Supplier Approval Management Program

CMP

Complaint Management Program

LMS

Learning Management System

QAS

Quality Assurance Services

OTHER IT PROJECTS

Website, Web Application Development, & Graphic Design (Static Website Creation, WordPress Development, Website Maintenance & Update, E-commerce, IT Business Solutions, Database Management, Process Automation, Logo Designs, and Graphics for Marketing and Training Materials).

About Us

Developed by Consultare Inc., a compliance company that provides Quality Systems (QS), Quality Management Systems (QMS), Regulatory and Certification Prerequisite Programs (PRP’s). 


Our foundation is in developing and implementing Programs, Policies, Protocols, Procedures, Forms for Records, and Lessons for Training regulated by the Code of Federal Regulations (CFR), and surveyed by accreditation bodies.

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