1331 Pine Trail

Tomball TX 77375

202-982-3002

Info@consultareinc.com

ALL INCLUSIVE SERVICES

Dietary Supplements, Quality Assurance, Regulatory, Certification, and Compliance Services

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

Introduction video

Compliance Services

STANDARDS

  • General Provisions
  • Manufacturing
  • Packaging
  • Labeling
  • Holding a Dietary Supplement
  • Definitions
  • Statutory Provisions
  • Regulations
  • Equipment and Utensils
  • Written Procedures
  • Calibration
  • Inspections
  • Cleaning
  • Sanitation
  • Design
  • Construction
  • Workmanship
  • Controls
  • Records
  • Packaging and Labeling Components and Operations
  • Written Procedures
  • Examinations
  • Quarantine Operations
  • Representative Sample Collection
  • QC Review and Approval
  • Unique Lot Identification
  • Receiving, Rejecting, Holding, and Releasing Operations
  • Records and recordkeeping
  • Laboratory Operations
  • Written Procedures
  • Test and Examination Methods
  • Laboratory Facilities
  • Components
  • Specifications
  • Laboratory Control Processes
  • QC Reviews and Approvals
  • Sampling Plans
  • Representative Samples
  • Standard Reference Materials
  • Records and Recordkeeping
  • Manufacturing Operations
  • Designs
  • Written Procedures
  • Washing, Cleaning and Sanitation
  • Precaution and Prevention of Contamination
  • Microorganism and Decomposition Controls
  • Water Use
  • Chemical and Microbiological Testing
  • Identification, Holding and Segregation
  • Mechanical Manufacturing Steps
  • Foreign Object Controls
  • Quarantine System
  • Disposition
  • Records and Recordkeeping
  • Returned Dietary Supplement Operations
  • Written Procedures
  • Identification
  • Quarantine System
  • QC Approval and Reevaluation
  • Material Review
  • Disposition Decision
  • Disposal
  • Destruction
  • Salvage Approvals
  • Redistribution
  • Reprocessing
  • Investigation of Manufacturing Process
  • Batch Traceability
  • Testing and Examinations
  • Specification Verification
  • Records and Recordkeeping
  • Personnel
  • Written Procedures
  • Microbial Contamination Prevention
  • Hygienic Practices
  • Qualifications
  • Supervisor Requirements
  • Records
  • Production and Process Control System
  • Production Controls
  • Process Controls
  • Quality Controls
  • Operations Controls
  • Specifications
  • Sampling
  • Reserve Samples
  • Material Review and Disposition
  • Treatments
  • In-Process Adjustments
  • Deviation
  • Reprocessing
  • Records
  • Master Manufacturing Record
  • Establishment
  • Formulation
  • Specifications
  • Controls
  • Procedures
  • Records
  • Name
  • Component List
  • Weight and Measures
  • Intentional Overages
  • Theoretical Yield
  • Descriptions
  • Written Instructions
  • Sampling
  • Cross Referencing
  • Manual Operations
  • Corrective Action Plans
  • Packaging and Labeling Operations
  • Written Procedures
  • Specifications
  • Reconciliation
  • Examination
  • Traceability
  • Filling, Assembling, Holding, Packaging and Labeling Operations
  • Cleaning and Sanitizing Controls
  • Batch, Lot and Control Number
  • Representative Sample Examinations
  • Disposition
  • Repackaging and Relabeling
  • QC Approval and Rejection Authority
  • Quarantine System
  • Records and Recordkeeping
  • Product Complaints Operations
  • Written Procedures
  • Identifications
  • Investigations
  • Personnel Qualifications
  • Reviews and Replies
  • Specification Verification
  • QC review and Approvals
  • Findings and Follow Up Actions
  • Batches and Records Traceability
  • Records and Recordkeeping
  • Records Made Available for FDA
  • Physical Plant and Grounds
  • Sanitation
  • Written Procedures
  • Cleaning
  • Pest Control
  • Design
  • Construction
  • Records
  • Quality Controls
  • Written Procedures
  • QC Personnel’s Responsibilities
  • Laboratory QC Operations
  • Material Review and Disposition QC Operations
  • Equipment, Instruments, and Controls
  • Components
  • Packaging
  • Labels and Labeling
  • Master Manufacturing Record
  • Batch Production Record
  • Manufacturing
  • Returns
  • Product Complaints
  • Records and Recordkeeping
  • Batch Production Record
  • Preparation
  • Production
  • Control
  • Records
  • Batch, Lot or Control Number
  • Equipment and Processing Lines Identifications
  • Date and Time of Maintenance, Cleaning and Sanitations
  • Component Unique Identification
  • Weight, Measure, actual and Theoretical Yield
  • Test and Examination
  • Monitoring Results
  • Documentation
  • Responsible Personnel
  • Approval, Rejection, Reprocessing and Release
  • Review and Disposition
  • Holding and Distributing Operations
  • Written Procedures
  • Conditions
  • Identification
  • In-Process Operations
  • Reserve Samples Retain Dates
  • Records and Recordkeeping

ACCREDITATION & CERTIFICATION

  • BRCGS – British Retail Consortium Global Standards
  • BSCG – Banned Substance Control Group
  • GMP – Good Manufacturing Practices
  • NSF – National Science Foundation
  • Organic
  • SQF – Safe Quality Foods
  • UL – Underwriters Laboratories
  • USP – U.S. Pharmacopeia

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 Care Management Systems (QCMS), 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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