GMP

Good manufacturing practice (GMP) is a set of controls for producing goods consistently and safely. GMP certification is relevant to manufacturers and other organisations that need to demonstrate control over their premises, processes, people and records. AuditCert International explains the process, agrees the audit scope and assesses your system.

What is GMP?

Good manufacturing practice (GMP) is a system of controls and working practices that helps organisations manufacture products consistently and safely. It covers how production is planned, carried out, checked and recorded, including the conditions, equipment and people involved.

GMP is not one single, universal standard with identical requirements for every industry. Applicable requirements depend on the product, sector, destination market and any regulatory or customer scheme. Before an assessment, the scope and applicable criteria need to be clear. GMP should not be confused with HACCP, which focuses on identifying and controlling food safety hazards; the approaches may be relevant together in food production.

An audit looks for evidence that documented arrangements are followed in practice. Depending on the agreed scope, this can include premises and hygiene, equipment condition and maintenance, process controls, staff competence, handling of materials and products, records, and the way problems are investigated and corrected. Certification is based on the applicable criteria and audit findings; it is not a substitute for regulatory approval or product testing.

Who needs GMP?

GMP is relevant to organisations that manufacture or process products where consistent production and controlled conditions matter. In Bangladesh, this may include food and beverage producers, pharmaceutical and healthcare product manufacturers, cosmetics and personal-care producers, and other goods manufacturers. The applicable GMP requirements vary by sector and product, so the right scope should be agreed before an audit.

Buyers may ask suppliers to demonstrate GMP arrangements during tendering, supplier approval or ongoing supply reviews. Regulators may set legal requirements for particular products and industries. Exporters may also need to meet requirements in destination markets. A certificate does not automatically meet every buyer or regulator requirement: confirm which scheme, criteria and evidence the relevant party accepts before applying.

What are the practical benefits?

  • Makes responsibilities, procedures and production controls clearer, helping staff follow consistent working practices.
  • Encourages attention to cleanliness, equipment condition and process controls that can affect product safety and quality.
  • Improves the traceability of activities through records, making it easier to review what happened during production.
  • Helps identify recurring problems and establish corrective action, rather than relying only on informal fixes.
  • Provides organised audit evidence that can support discussions with customers and supplier approval teams.
  • Gives management a structured basis for reviewing performance and pursuing continual improvement.

How does certification with AuditCert International work?

The process begins with an initial assessment to understand your business and agree the scope. AuditCert International plans the audit with you and reviews your system against the applicable criteria. Certification depends on the assessment findings and the certification decision; it is not promised in advance.

  1. Enquiry and application

    Describe your organisation, products or activities, locations and the certification you are seeking. AuditCert International can explain what is involved and the next step.

  2. Scope review

    The organisation’s activities and relevant sites are considered so the assessment scope and applicable GMP criteria can be agreed.

  3. Audit planning

    Audit arrangements are planned with you. You will need to make relevant processes, records and personnel available for review.

  4. Audit and evidence review

    The auditor assesses the arrangements against the agreed criteria, reviewing documents and records and observing relevant activities. Findings are discussed as part of the audit process.

  5. Findings and corrective action

    Where issues are identified, the organisation is responsible for addressing them and providing appropriate evidence. The auditor or certification process reviews evidence in line with the applicable procedures.

  6. Certification decision

    The audit findings are reviewed before a certification decision is made. If certification is granted, the certificate relates to its stated scope and applicable requirements.

  7. Surveillance and improvement

    Follow-up surveillance activities help check that the certified system continues to be maintained. Audit feedback can support ongoing improvement.

What should you prepare?

Prepare information that helps the audit team understand how your GMP arrangements work and verify that documented controls are followed. The exact evidence depends on your products, operations and agreed criteria.

  • Documents: A description of products and processes; organisation responsibilities; relevant procedures and work instructions; hygiene and cleaning arrangements; process controls; equipment maintenance arrangements; and procedures for handling nonconforming products, complaints and corrective action, where applicable.
  • Records: Production and inspection records; cleaning and maintenance records; staff training or competence records; material and product traceability records; monitoring results; and records of incidents, complaints and corrective actions, where these apply to your scope.
  • People: A management contact who can explain the system, process owners and production staff who carry out the work, and personnel responsible for quality, hygiene, maintenance or other controls within the audit scope.

Keep records accessible and ensure the people involved understand their responsibilities. Auditors assess evidence rather than the presence of paperwork alone, so staff should be able to describe how procedures are applied in routine work.

How long does it take, and what affects time and cost?

The time and cost depend on the organisation and the agreed audit scope; no duration or price is stated here. Relevant factors include the number and type of sites, the nature and complexity of production, the range of products and processes, the applicable criteria, the readiness and availability of records, and the time needed to address audit findings.

The enquiry and scope review establish what assessment is required. Audit planning and implementation then depend on coordinating access to sites, processes and personnel. If records are incomplete or controls are not consistently followed, additional work may be needed to address findings before a certification decision. Contact AuditCert International with a short description of your organisation and needs to discuss the process and request a quote.

Why work with AuditCert International?

AuditCert International is an accredited certification body offering management system certification and services including GMP, HACCP, HALAL, C-TPAT and social compliance audits, as well as training. The company serves Bangladesh and organisations worldwide.

For GMP, the stated process is to understand your business, agree the scope, plan the audit with you and review your system against the applicable criteria. The certification process includes feedback to support continual improvement. Certification is determined by audit evidence and the applicable decision process; AuditCert International does not promise a particular result. A certification body assesses systems and should not provide consultancy for the systems it certifies.

Ready to talk about GMP?

Describe your organization and the standard you are working toward. We will reply with the next step.

Contact us +8801718008488

Frequently asked questions

Is GMP the same as HACCP?

No. GMP covers broader production practices and controls, while HACCP is a method for identifying and controlling food safety hazards. They may both be relevant to a food business, depending on its activities and applicable requirements. The audit scope should make clear which criteria are being assessed; a GMP assessment does not automatically replace HACCP or regulatory obligations.

Does GMP certification ensrue that every product is safe?

No. Certification is an assessment of an organisation’s system against the agreed criteria and scope. It does not promise that every product is free from risk or replace product testing, legal compliance or regulatory oversight. Organisations remain responsible for controlling production and meeting the requirements that apply to their products and markets.

What does a GMP auditor check?

An auditor checks evidence against the agreed criteria. Depending on the scope, this may include procedures and records, production activities, premises and hygiene, equipment maintenance, staff competence, traceability, monitoring and how problems are corrected. The auditor considers whether documented arrangements are implemented in practice, not only whether procedures exist.

Which GMP standard or version should my organisation use?

There is no single GMP standard or version stated for every industry. Applicable requirements depend on the product, sector, regulator, customer scheme and destination market. Identify what your buyer or regulator expects before applying, then discuss the relevant criteria and scope with AuditCert International. This helps avoid assessing against a scheme that does not meet the requirement.

What happens if the audit identifies issues?

If the audit identifies issues, your organisation is responsible for addressing them and providing appropriate evidence. The findings and any required follow-up are handled under the applicable audit and certification procedures. A certification decision is made after the relevant evidence has been reviewed; certification is not granted simply because an audit has taken place.