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

**GMP establishes minimum standards for manufacturing controls to ensure products are consistently produced and controlled to meet predefined quality criteria.** It prevents contamination, mix-ups, mislabeling, and variability through preventive systems like validated processes, independent quality oversight, and the "5 Ps" (People, Products, Procedures, Processes, Premises), rather than relying solely on end-product testing.

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

**GMP compliance is legally required for manufacturers of pharmaceuticals, biologics, APIs, and related products under FDA 21 CFR Parts 210/211, EU EudraLex Volume 4, and WHO GMP.** This includes drug product firms, API producers (ICH Q7), contract manufacturers (EU Chapter 7), and supply chain partners handling materials, with obligations extending to sterile products (EU Annex 1, applicable since 25 August 2024) and biologics (EU Annex 2, since 26 June 2018).

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

**GMP does not mandate third-party certification but requires regular regulatory inspections by authorities like FDA or EMA, plus internal audits and self-inspections.** Organizations must maintain inspection readiness, with PIC/S and MRAs enabling mutual recognition; EU QP certification (Annex 16) is required for batch release, but no universal external certifier exists.

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, with annual product quality reviews (PQR) per 21 CFR §211.180(e) and ICH Q7.** Requalification follows change triggers, with ongoing monitoring via CAPA, management review (ICH Q10), and environmental checks; EU Annex 15 specifies validation requalification schedules.

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

**Non-compliance with GMP triggers regulatory actions including FDA Form 483 observations, Warning Letters, import alerts, product seizures, recalls, and fines up to $50k per day.** Severe cases lead to consent decrees, manufacturing halts, multimillion-dollar remediation, market exclusion, and criminal liability for adulteration or fraud.

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

**GMP cannot be directly mapped as it is a standalone regulatory framework, though principles align with ICH Q7 (API), Q9 (QRM), Q10 (PQS), PIC/S, and WHO guidance.** Regional variations persist (e.g., FDA 21 CFR vs. EU Annexes), requiring tailored implementation without substitution.

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

**The first step is conducting a comprehensive gap analysis against applicable regulations like 21 CFR Parts 210/211 or EU GMP, followed by developing a Validation Master Plan (VMP).** This identifies risks, prioritizes remediation via ICH Q9, and establishes a Pharmaceutical Quality System (PQS) with executive sponsorship.

What is the primary objective of **AS9120B**?

**AS9120B's primary objective is to establish a quality management system (QMS) for organizations that procure, store, split, and resell aerospace parts without altering product characteristics.** It builds on ISO 9001:2015's 10-clause structure, adding over 100 distributor-specific requirements for **traceability**, **counterfeit/suspected unapproved parts prevention**, **configuration management**, and **external provider controls** to mitigate supply chain risks like documentation errors and loss of chain-of-custody.

Who is legally or professionally required to comply with **AS9120B**?

**AS9120B applies to stockist distributors, pass-through distributors, and organizations performing batch splitting in aviation, space, and defense supply chains.** It targets entities that purchase, store, and resell parts without modification; certification is not legally mandatory but is a commercial requirement from OEMs and primes, with 2,442 global certifications (836 in the U.S.) as of May 2023 for OASIS visibility and market access.

Does **AS9120B** require an external audit or third-party certification?

**Yes, AS9120B requires third-party certification through accredited bodies via Stage 1 (documentation) and Stage 2 (implementation) audits per AS9101F.** Certification, valid for three years with annual surveillance, lists organizations in the IAQG OASIS database, demonstrating QMS conformity to aerospace customers.

How often should an assessment for **AS9120B** be performed?

**AS9120B requires internal audits at planned intervals to cover all processes annually, plus management reviews at defined intervals.** External surveillance audits occur annually post-certification, with full recertification every three years; assessments evaluate QMS effectiveness, risks, supplier performance, and Clause 9 monitoring.

What are the consequences of non-compliance with **AS9120B**?

**Non-compliance with AS9120B risks contract disqualification by OEMs, exclusion from supply chains, and major audit findings on traceability or counterfeit controls.** It leads to operational disruptions, recalls, reputational damage, and potential legal liabilities for safety incidents, as certification is a de facto market entry criterion.

An **AS9120B** be mapped to other international frameworks?

**Yes, AS9120B aligns directly with ISO 9001:2015's high-level structure, enabling seamless mapping of its 10 clauses.** Aerospace additions integrate with IAQG standards like AS9100, supporting multi-standard QMS without clause exclusions, justified via documented scope (Clause 4.3).

What is the first step to begin implementing **AS9120B**?

**The first step is conducting a gap analysis against AS9120B clauses using a certified checklist to identify deficiencies in context, scope, and distributor controls.** Form a cross-functional team, document scope/“not applicable” justifications (e.g., Clause 8.3 design), and prioritize risks like supplier evaluation and traceability.

GMP vs AS9120B

Standards Comparison

GMP

Mandatory

1963

Regulatory framework ensuring consistent manufacturing quality standards

AS9120B

Mandatory

2016

Aerospace QMS standard for parts distributors

Quick Verdict

GMP enforces manufacturing controls for pharma safety worldwide, preventing contamination via validation and oversight. AS9120B certifies aerospace distributors for traceability and counterfeit prevention. Companies adopt GMP for legal compliance, AS9120B for supply chain access.

Manufacturing Quality

GMP

Good Manufacturing Practices (GMP)

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Requires preventive controls beyond final testing
Independent quality unit approves product release
Quality Risk Management ensures proportional controls
Validated processes and equipment qualification mandatory
Robust documentation for full traceability

Quality Management

AS9120B

AS9120B Quality Management Systems - Distributors

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Counterfeit and unapproved parts prevention
Traceability and chain-of-custody controls
External provider evaluation and flowdown
Configuration management for split lots
Risk-based operational planning and preservation

Detailed Analysis

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

GMP Details

What It Is

Good Manufacturing Practices (GMP), also known as cGMP, is a regulatory framework establishing minimum standards for manufacturing controls in pharmaceuticals, biologics, and related products. Its primary purpose is ensuring products are consistently produced to meet quality, safety, and efficacy criteria through preventive systems spanning people, premises, processes, and documentation. It employs a risk-based approach via Quality Risk Management (QRM).

Key Components

Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products)
Elements include quality management system (PQS), validation, independent Quality Control Unit, CAPA, change control, supplier oversight, and data integrity (ALCOA++)
Built on ICH Q9/Q10, FDA 21 CFR Parts 210/211, EU EudraLex Volume 4, WHO GMP
Compliance via inspections, no central certification but enforceable through audits

Why Organizations Use It

Legal mandate prevents recalls, fines, market bans
Reduces contamination/mix-up risks, ensures supply reliability
Builds stakeholder trust, enables market access
Drives efficiency, continual improvement

Implementation Overview

Phased: gap analysis, Validation Master Plan, training, qualification (IQ/OQ/PQ), audits
Applies to pharma manufacturers globally; scales by size/risk
Requires ongoing internal audits, regulatory inspections

AS9120B Details

What It Is

AS9120B is the IAQG's quality management system (QMS) standard for aerospace distributors, based on ISO 9001:2015's 10-clause structure. It targets organizations procuring, storing, splitting, and reselling parts without alteration, emphasizing risk-based thinking to mitigate supply chain risks like traceability loss and counterfeits.

Key Components

Over 100 aerospace-specific requirements beyond ISO 9001.
Core areas: context analysis, leadership, planning, support, operations (traceability, preservation, counterfeit prevention), performance evaluation, improvement.
Built on PDCA cycle; requires documented information, internal audits, management reviews.
Certification via accredited bodies, OASIS listing.

Why Organizations Use It

Commercial necessity for OEM/Tier-1 approval.
Reduces risks of nonconformities, counterfeits; enhances traceability.
Builds customer trust, market access (2,442 global certifications).
Improves efficiency, competitiveness in ASD supply chains.

Implementation Overview

Phased: gap analysis, process design, training, audits (6-12 months).
Applies to distributors globally; scales by size.
Involves risk registers, supplier controls, IT for traceability.

Key Differences

Aspect	GMP	AS9120B
Scope	Manufacturing controls for pharmaceuticals, facilities, processes, documentation	Distribution controls for aerospace parts, traceability, counterfeit prevention
Industry	Pharma, biologics, food, cosmetics globally	Aerospace distributors worldwide, aviation/space/defense
Nature	Enforceable regulations with inspections, warning letters	Voluntary certification standard based on ISO 9001
Testing	Process validation, equipment qualification, stability testing	Internal audits, supplier verification, certification audits
Penalties	Recalls, fines, shutdowns, legal enforcement	Loss of certification, market exclusion, no legal fines

Scope

GMP

Manufacturing controls for pharmaceuticals, facilities, processes, documentation

AS9120B

Distribution controls for aerospace parts, traceability, counterfeit prevention

Industry

GMP

Pharma, biologics, food, cosmetics globally

AS9120B

Aerospace distributors worldwide, aviation/space/defense

Nature

GMP

Enforceable regulations with inspections, warning letters

AS9120B

Voluntary certification standard based on ISO 9001

Testing

GMP

Process validation, equipment qualification, stability testing

AS9120B

Internal audits, supplier verification, certification audits

Penalties

GMP

Recalls, fines, shutdowns, legal enforcement

AS9120B

Loss of certification, market exclusion, no legal fines

Frequently Asked Questions

Common questions about GMP and AS9120B

GMP FAQ

AS9120B FAQ

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GMP

AS9120B

Quick Verdict

GMP

Key Features

AS9120B

Key Features

Detailed Analysis

GMP Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

AS9120B 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?

Does 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?

AS9120B FAQ

What is the primary objective of AS9120B?

Who is legally or professionally required to comply with AS9120B?

Does AS9120B require an external audit or third-party certification?

How often should an assessment for AS9120B be performed?

What are the consequences of non-compliance with AS9120B?

An AS9120B be mapped to other international frameworks?

What is the first step to begin implementing AS9120B?

You Might also be Interested in These Articles...

CIS Controls v8.1 for Cloud & SaaS: A Practical Safeguard Playbook for AWS/Azure/GCP and Microsoft 365

SEC Cybersecurity Rules Materiality Determination Framework: Step-by-Step Guide with Checklists and Real-World Examples

PDPA Cross-Border Transfer Rules Decoded: Singapore, Thailand, and Taiwan Mechanisms Compared with Practical Implementation Templates

Run Maturity Assessments with GRADUM

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ISO 45001 vs ISO 27017

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