What is the primary objective of **GMP**?

**The primary objective of GMP is to ensure products are consistently produced and controlled to meet predefined quality standards, preventing contamination, mix-ups, mislabeling, and variability through preventive controls rather than end-product testing alone.** This encompasses the "5 Ps"—People, Products, Procedures, Processes, Premises—spanning raw material receipt to distribution, as codified in FDA 21 CFR Parts 210/211, EU EudraLex Volume 4, and WHO GMP.

Who is legally or professionally required to comply with **GMP**?

**GMP compliance is legally required for manufacturers of pharmaceuticals, biologics, APIs, and related products in regulated jurisdictions like the US (FDA 21 CFR Parts 210/211) and EU (EudraLex Volume 4).** This includes contract manufacturers (CMOs), with sponsors accountable via technical/quality agreements; applies to facilities handling high-risk products like sterile injectables; WHO GMP baselines emerging markets.

Oes **GMP** require an external audit or third-party certification?

**GMP does not universally mandate third-party certification but requires internal audits/self-inspections and is enforced via regulatory inspections by authorities like FDA or EMA.** PIC/S and MRAs enable mutual recognition; EU Qualified Person (QP) certifies batches under Annex 16; no ISO-style certification, but inspections yield Form 483s or compliance statements.

How often should an assessment for **GMP** be performed?

**GMP assessments, including internal audits and self-inspections, must be conducted at planned intervals based on risk, typically annually or more frequently for high-risk areas.** FDA expects ongoing monitoring via CAPA and management review (ICH Q10); EU GMP mandates periodic product quality reviews (21 CFR §211.180(e)); requalification post-maintenance or changes.

What are the consequences of non-compliance with **GMP**?

**Non-compliance with GMP triggers regulatory actions including Form 483 observations, Warning Letters, import alerts, product recalls, fines up to $50k/day (FDA), manufacturing halts, and potential criminal prosecution.** Historical cases like Elixir Sulfanilamide recall demonstrate supply disruptions; EU QP liability adds personal accountability.

An **GMP** be mapped to other international frameworks?

**Yes, GMP maps closely to ICH Q7 (API), Q9 (QRM), Q10 (PQS), PIC/S, and WHO guidance through harmonized principles like quality systems, validation, and risk management.** Core pillars—independent quality units, documentation, process controls—align across FDA, EU, WHO; MRAs reduce duplication but regional annexes (e.g., EU Annex 1 sterile) require overlays.

What is the first step to begin implementing **GMP**?

**The first step to implement GMP is conducting a comprehensive gap analysis against applicable regulations (e.g., 21 CFR 211, EU GMP) to identify deficiencies in the 5 Ps and develop a Validation Master Plan (VMP).** Engage cross-functional teams for risk-based prioritization, followed by executive sponsorship and resource allocation.

What is the primary objective of **FSSC 22000**?

**FSSC 22000's primary objective is to ensure certified organizations consistently provide safe food through a GFSI-benchmarked Food Safety Management System (FSMS).** It integrates **ISO 22000:2018** requirements, sector-specific Prerequisite Programs (PRPs) like **ISO/TS 22002-1** for food manufacturing, and FSSC Additional Requirements covering food defense, fraud mitigation, and quality culture. This enables supply-chain trust via a public register of 40,059 certified sites across categories B–K (e.g., manufacturing, packaging, logistics).

Who is legally or professionally required to comply with **FSSC 22000**?

**FSSC 22000 is not legally mandatory but professionally required for food chain organizations seeking GFSI recognition and retailer contracts.** It applies to ISO 22003-1:2022 categories including C (food manufacturing), I (packaging), G (transport/storage), and FII (brokers), spanning 40,059 certified sites worldwide. Retailers like supermarkets demand it for suppliers to ensure FSMS integrity and reduce audit duplication.

Does **FSSC 22000** require an external audit or third-party certification?

**Yes, FSSC 22000 mandates third-party certification by licensed Certification Bodies (CBs) accredited under ISO/IEC 17021-1:2015 and ISO 22003-1:2022.** CBs (134 licensed globally) conduct initial, surveillance (annual), and recertification audits (every 3 years), with ≥50% time on operational PRPs, controls, and traceability. Certificates are issued only after closing nonconformities.

How often should an assessment for **FSSC 22000** be performed?

**FSSC 22000 requires annual surveillance audits and full recertification every 3 years by licensed CBs.** Internal audits must cover the full FSMS (ISO 22000 clauses 4–10, PRPs, Additional Requirements) at least annually, with management reviews incorporating trend data from environmental monitoring and quality controls. BoS decisions trigger interim assessments.

What are the consequences of non-compliance with **FSSC 22000**?

**Non-compliance with FSSC 22000 results in nonconformity closure demands, certificate suspension, or withdrawal by the CB.** Organizations must notify CBs within **3 working days** of serious events (e.g., recalls, fraud). Repeated major nonconformities lead to exclusion from the public register, lost GFSI recognition, market de-listing by retailers, and supply-chain rejection across 134 CBs.

Can **FSSC 22000** be mapped to other international frameworks?

**Yes, FSSC 22000's ISO 22000:2018 harmonized structure enables seamless mapping to ISO 9001, ISO 14001, and other ISO management systems.** Shared elements include PDCA cycles, leadership (Clause 5), internal audits (Clause 9), and corrective actions (Clause 10). PRPs and Additional Requirements integrate with quality controls, reducing duplication in multi-standard environments.

What is the first step to begin implementing **FSSC 22000**?

**The first step to implement FSSC 22000 is to define the precise certification scope per ISO 22003-1:2022 categories and conduct a gap analysis against ISO 22000:2018, applicable PRPs, and Additional Requirements.** Download free Scheme Parts 1–5 from Foundation FSSC, classify activities (e.g., Category C for manufacturing), and convene senior leadership to approve the FSMS scope and project plan.

GMP vs FSSC 22000

Standards Comparison

GMP

Mandatory

1963

Regulatory standards for pharmaceutical manufacturing quality controls

FSSC 22000

Voluntary

2023

GFSI-benchmarked certification scheme for food safety management.

Quick Verdict

GMP enforces manufacturing controls for pharma and food via regulations and inspections, ensuring product quality. FSSC 22000 certifies food chain safety through ISO 22000, PRPs and audits. Companies adopt GMP for legal compliance; FSSC for global market access.

Manufacturing Quality

GMP

Good Manufacturing Practice (GMP)

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Requires independent Quality Control Unit authority
Prioritizes preventive controls over end-product testing
Integrates Quality Risk Management (QRM) principles
Mandates lifecycle process and equipment validation
Enforces ALCOA++ data integrity and traceability

Food Safety

FSSC 22000

Food Safety System Certification 22000

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

GFSI-benchmarked for global market access
Integrates ISO 22000, PRPs, additional requirements
Food defense and fraud vulnerability assessments
Sector-specific PRPs across food chain categories
Rigorous audit duration and reporting rules

Detailed Analysis

A comprehensive look at the specific requirements, scope, and impact of each standard.

GMP Details

What It Is

Good Manufacturing Practice (GMP) is a legally enforceable regulatory framework for pharmaceuticals, biologics, and related products. It establishes minimum standards ensuring consistent production and control to meet quality criteria, preventing contamination, mix-ups, and variability. Core approach: preventive Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS) per ICH Q10, spanning FDA 21 CFR Parts 210/211, EU EudraLex Volume 4, and WHO GMP.

Key Components

**5 Ps frameworkPeople, Premises, Processes, Procedures, Products.
Independent Quality Control Unit or Qualified Person (QP) oversight.
Documentation, validation (IQ/OQ/PQ), CAPA, change control, audits.
Data integrity via ALCOA++; no fixed control count, but comprehensive subparts/chapters. Compliance enforced via inspections, warning letters.

Why Organizations Use It

Meets legal mandates, avoids recalls/fines.
Reduces patient risks, ensures market access.
Drives efficiency, supply reliability, reputation.
Enables global harmonization (ICH/PIC/S).

Implementation Overview

Phased: gap analysis, Validation Master Plan, QMS build, training, qualification, audits. Applies to manufacturers globally; resource-intensive for pharma/biologics. Ongoing via continual improvement.

FSSC 22000 Details

What It Is

FSSC 22000 (Food Safety System Certification 22000) is a GFSI-benchmarked certification scheme for Food Safety Management Systems (FSMS). It applies across food chain categories like manufacturing, packaging, and logistics. The scheme uses a risk-based, PDCA management system approach anchored in ISO 22000:2018.

Key Components

**Three pillarsISO 22000:2018 clauses 4–10, sector-specific PRPs (e.g., ISO/TS 22002 series), and FSSC Additional Requirements (e.g., food defense, fraud, allergens).
Overlaps with HACCP principles for hazard control.
Certification via licensed bodies per ISO 22003-1:2022.

Why Organizations Use It

Meets buyer requirements for global trade.
Reduces recalls, enhances supply chain trust.
Supports SDGs like food loss reduction.
Builds reputation via public register.

Implementation Overview

Phased: gap analysis, FSMS build, PRPs, audits.
For food manufacturers, caterers, packagers worldwide.
Requires Stage 1/2 audits, surveillance; 6–24 months typical.

Key Differences

Aspect	GMP	FSSC 22000
Scope	Manufacturing controls: facilities, equipment, processes, documentation	Food safety management: ISO 22000 + PRPs + additional requirements
Industry	Pharma, biologics, devices, cosmetics, food	Food chain: manufacturing, packaging, catering, storage, trading
Nature	Regulatory requirements, enforceable by inspections	GFSI-benchmarked voluntary certification scheme
Testing	Process validation, equipment qualification, inspections	Certification audits, surveillance, recertification every 3 years
Penalties	Warning letters, recalls, shutdowns, fines	Loss of certification, market access denial

Scope

GMP

Manufacturing controls: facilities, equipment, processes, documentation

FSSC 22000

Food safety management: ISO 22000 + PRPs + additional requirements

Industry

GMP

Pharma, biologics, devices, cosmetics, food

FSSC 22000

Food chain: manufacturing, packaging, catering, storage, trading

Nature

GMP

Regulatory requirements, enforceable by inspections

FSSC 22000

GFSI-benchmarked voluntary certification scheme

Testing

GMP

Process validation, equipment qualification, inspections

FSSC 22000

Certification audits, surveillance, recertification every 3 years

Penalties

GMP

Warning letters, recalls, shutdowns, fines

FSSC 22000

Loss of certification, market access denial

Frequently Asked Questions

Common questions about GMP and FSSC 22000

GMP FAQ

FSSC 22000 FAQ

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GMP

FSSC 22000

Quick Verdict

GMP

Key Features

FSSC 22000

Key Features

Detailed Analysis

GMP Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

FSSC 22000 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

GMP FAQ

What is the primary objective of GMP?

Who is legally or professionally required to comply with GMP?

Oes GMP require an external audit or third-party certification?

How often should an assessment for GMP be performed?

What are the consequences of non-compliance with GMP?

An GMP be mapped to other international frameworks?

What is the first step to begin implementing GMP?

FSSC 22000 FAQ

What is the primary objective of FSSC 22000?

Who is legally or professionally required to comply with FSSC 22000?

Does FSSC 22000 require an external audit or third-party certification?

How often should an assessment for FSSC 22000 be performed?

What are the consequences of non-compliance with FSSC 22000?

Can FSSC 22000 be mapped to other international frameworks?

What is the first step to begin implementing FSSC 22000?

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