QMS Implementation Consulting for FDA Companies

A QMS that runs on the floor, not just on paper

A Comprehensive Implementation Guide by J&J Compliance Consulting Group (JJCC Group)

A quality management system (QMS) is the set of procedures, records and responsibilities that keep product quality under control. FDA inspects it, customers audit it, and your team lives in it every day. Our founder has built hundreds of quality systems across every major FDA-regulated sector. We build yours to fit your size, product and regulation.

The building blocks every QMS needs

Regardless of industry, a robust QMS is constructed from a common set of foundational elements. JJCC Group ensures each of these pillars is designed, documented, and embedded into daily operations:

Document control:

approved, current procedures and controlled forms.

Risk management:

decisions based on product and patient risk.

CAPA:

investigation, root cause and verified fixes.

Change control:

no change without review and approval.

Training:

qualified people, with records to prove it.

Supplier control:

qualified suppliers and quality agreements.

Internal audits and management review:

the system checks itself.

Data integrity:

records that are complete and trustworthy.

Pharmaceuticals and Drug Products

Governing Regulations: 21 CFR Part 210 (general cGMP for drugs) and 21 CFR Part 211 (cGMP for finished pharmaceuticals). Active pharmaceutical ingredients are additionally guided by ICH Q7.

Drug manufacturers are held to the most rigorous quality expectations under the Current Good Manufacturing Practice (cGMP) regulations. 21 CFR Part 211 prescribes detailed requirements covering organization and personnel, buildings and facilities, equipment, control of components and drug product containers, production and process controls, packaging and labeling, holding and distribution, laboratory controls, records and reports, and returned and salvaged drug products.

How we implement

Gap assessment: against your regulation.
Roadmap: with priorities, owners and dates.
Document development: quality manual, SOPs, forms and work instructions.
Training: for every role.
Verification: internal audit and mock inspection.

We work with paper systems or eQMS software, and can help you choose and validate one.

Medical Devices

Governing Regulations: 21 CFR Part 820 (Quality System Regulation). The FDA is harmonizing Part 820 with ISO 13485:2016 through the Quality Management System Regulation (QMSR), so JJCC Group designs systems compliant with both frameworks.

The medical device QMS centers on design controls, a requirement unique to this sector. 21 CFR Part 820 mandates management responsibility, design controls, document controls, purchasing controls, identification and traceability, production and process controls, acceptance activities, nonconforming product handling, CAPA, labeling, handling, storage, distribution, installation, servicing, and statistical techniques.

What we add for each industry

Drugs EQuality unit, process validation, batch records, stability, OOS
Medical devices ISO 13485 under the QMSR, design controls (ISO 13485 clause 7.3), Medical Device File, risk file
Dietary supplements Specifications, master and batch records, identity testing, reserve samples
Food Food safety plan, preventive controls, supply-chain program, recall plan
Cosmetics ISO 22716 practices, safety substantiation, adverse event records
Tobacco Controls ready for FDA’s proposed manufacturing practice rule; PMTA manufacturing data

Dietary Supplements

Governing Regulations: 21 CFR Part 111 (cGMP for dietary supplements) and 21 CFR Part 117 where facility-level food safety provisions apply. Adverse event reporting follows 21 CFR Part 4 and the DSHEA framework.

Dietary supplement manufacturers must establish controls ensuring identity, purity, strength, and composition of their products. 21 CFR Part 111 requires written procedures for quality control operations, master manufacturing records (MMR), batch production records (BPR), component and product testing, and handling of returned products and complaints.

JJCC Group QMS Services for Supplement Manufacturers

Master and Batch Manufacturing Records: Development of compliant MMR and BPR templates capturing every specification and step required under Subpart E.
Identity and Specification Testing: Establishment of component, in-process, and finished-product specifications with scientifically valid test methods.
Quality Control Unit: Definition of QC responsibilities, material review, and disposition authority per §111.65.
Complaint and Adverse Event Systems: Procedures for serious adverse event reporting and product complaint investigation.

Food Manufacturers

Governing Regulations: 21 CFR Part 117 (cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) under FSMA, with 21 CFR Part 507 applying to animal food and 21 CFR Part 120/123 for juice and seafood HACCP.

Modern food safety management is built on the Food Safety Modernization Act (FSMA), which shifted the focus from reaction to prevention. 21 CFR Part 117 requires a written food safety plan, hazard analysis, preventive controls, supply-chain controls, a recall plan, and current good manufacturing practices, overseen by a Preventive Controls Qualified Individual (PCQI).

JJCC Group QMS Services for Food Manufacturers

Food Safety Plan Development: Authoring of HACCP and HARPC-based plans, including hazard analysis and preventive control determination.
Preventive Controls: Design of process, sanitation, allergen, and supply-chain preventive controls with monitoring, corrective actions, and verification.
Sanitation and Environmental Monitoring: GMP programs, sanitation SOPs, and environmental monitoring for pathogens.
Recall and Traceability: Written recall plans and traceability systems supporting rapid product retrieval.

Cosmetics

Governing Regulations: The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 expanded FDA authority, with cGMP requirements being established under 21 CFR (forthcoming cosmetic GMP rule), supported by existing 21 CFR Parts 700-740 governing cosmetic labeling and prohibited ingredients.

MoCRA introduced mandatory facility registration, product listing, adverse event reporting, safety substantiation, and cosmetic Good Manufacturing Practices. While FDA finalizes its cosmetic GMP regulation, JJCC Group builds QMS programs aligned with ISO 22716 (Cosmetics GMP) and anticipated FDA expectations to ensure a smooth transition once the rule is enforced.

JJCC Group QMS Services for Cosmetic Manufacturers

MoCRA Compliance Program: Facility registration, product listing, and responsible-person designation support.
Cosmetic GMP to ISO 22716: Implementation of production, quality control, personnel, and premises controls.
Safety Substantiation: Documentation files demonstrating adequate substantiation of product safety.
Adverse Event Reporting: Procedures for capturing and reporting serious adverse events as required under MoCRA.

Tobacco Products

Governing Regulations: 21 CFR Part 1100 series and the Tobacco Control Act, with FDA’s proposed Tobacco Product Manufacturing Practice (TPMP) requirements under section 906(e) of the Federal Food, Drug, and Cosmetic Act. Establishment registration and product listing fall under 21 CFR Part 1140 and related provisions.

Tobacco product manufacturers, including makers of cigarettes, cigars, and electronic nicotine delivery systems (ENDS), face an evolving regulatory landscape. The FDA’s proposed manufacturing practice requirements address manufacturing controls, design and process specifications, contamination prevention, and recordkeeping. JJCC Group helps manufacturers prepare for TPMP compliance and supports the quality documentation needed for Premarket Tobacco Product Applications (PMTA).

JJCC Group QMS Services for Tobacco Manufacturers

TPMP Readiness: Manufacturing control systems, process specifications, and contamination prevention programs aligned with proposed FDA requirements.
PMTA Quality Support: Quality and stability documentation supporting premarket application submissions.
Establishment Registration: Support for registration, product listing, and ingredient reporting obligations.
Recordkeeping Systems: Batch records, specifications, and traceability infrastructure for finished tobacco products.

Why Partner with JJCC Group

Building a QMS that survives an FDA inspection requires more than templated documents; it demands deep regulatory expertise applied to the realities of your operation. J&J Compliance Consulting Group delivers a structured implementation methodology: an initial gap assessment against the applicable 21 CFR Part, a prioritized remediation roadmap, hands-on development of your document hierarchy, staff training, and a verification phase that confirms your systems function as designed. Our consultants bring practical experience across SOPs, CAPA, validation, data integrity, FDA 21 CFR Parts 210/211/820, EU GMP, ICH guidelines, and ISO 13485, allowing us to serve multi-product and contract manufacturers operating under several regulatory regimes simultaneously.

From a single SOP to a complete enterprise quality system, JJCC Group scales its services to your needs, helping you move from uncertainty to audit-ready confidence. Through ThecGMPAcademy, we also offer training resources that reinforce a culture of quality long after implementation is complete.