For the purpose of preventing adulteration, good manufacturing practice regulations define minimum criteria for product manufacture. Better yet, sound manufacturing practices must become a way of life for a firm, which it applies through its quality management system to preserve its consumers’ health and safety while increasing revenues.
The 10 principles of the standard are more important for good manufacturing practice certification in Singapore. These principles include writing step-by-step instructions that serve as a road map for GMP compliance.
Cleaning and hygiene should be practiced on a daily basis in order to protect your products against contamination. GMP certification in Singapore focuses on systematically controlling the processes that are related to your products, such as manufacturing, labeling, testing, distribution, and marketing, as well as controlling the frequency of inspections and inspections of your products.
It is possible to become certified in accordance with Good Manufacturing Practices (GMP) through an independent verification and certification scheme, which ensures the fundamental manufacturing practices and prerequisites necessary for the HACCP food safety program.
Who needs GMP Certification in Singapore?
Applicants for GMP accreditation include pharmaceutical companies, bulk drug API manufacturers, formulators, and food processors.
To be compliant with Good Manufacturing Practices (GMP), all makers and assemblers of medical goods (Western Medicines and Chinese Proprietary Medicines) must adhere to the Medicines Act.
Health Products (Good Manufacturing Practice Certificate — Cosmetic Products) is issued by the Health Sciences Authority in Singapore in accordance with the provisions of sections 71 and 72 of the Health Products Act, with the permission of the Minister for Health.
A cosmetic product is defined as a cosmetic product that meets the requirements of the First Schedule to the Act and is as stated and described in that framework.
In many different industries, including pharmaceutical manufacturing, manufacturing of other products such as foods, and food manufacturing, good manufacturing practice (GMP) is the most recognized method of delivering customer pride and controlling the quality of their product and service within their chosen sector. Not only can GMP be used to provide enhancements and aid in the assurance of quality, but accreditation is also often viewed as an assurance of uniformity of products and offerings across borders, languages, and cultural boundaries. As a result, possessing GMP accreditation might be regarded acceptable both from a reputational and a practical standpoint.
Good Manufacturing Practices (GMP) for local manufacturers:
A voluntary Good Manufacturing Practice (GMP) certification system is available to local producers of the following items who wish to have their products certified by Health Safety Authority Singapore for compliance with applicable GMP standards:
- Therapeutic items
- Chinese proprietary medication
- Pharmaceutical active
- Medicated oils and balms
To submit an application for a GMP certificate, you must be authorized to do so by your organization as the person responsible, such as the managing director, quality assurance/quality control manager, or production manager.
Audit for Good Manufacturing Practices Certification
HSA GMP auditors will complete the GMP certification audit, and if they determine that your company has demonstrated satisfactory compliance with the required GMP standard, the HSA (Health Safety Authority) will issue a certificate in the name of your company as it is registered with the Accounting and Corporate Regulatory Authority. The scope of certification is often decided by the extent of the actual audit completed at the manufacturing site and the types of dosage forms or range of goods created at the manufacturing facility.
A Good Manufacturing Practices (GMP) certificate is valid for three years from the date of assessment and cannot be renewed or changed beyond that time. If you wish to get recertified after your current certification has expired, you will need to submit a new certification application. GMP audits will be performed.
The following is the procedure to obtain a certificate:
- Application: The Application Form has been received.
- Application review: This includes a review of the application for further certification as well as the allocation of auditors for the audits.
- Contract Review: The commercial team will conduct a review of the contract throughout the whole procedure.
- Quotation/Agreement: Providing the quotation/agreement to the applicant in order for the applicant to accept the quotation for the certification to be completed.
- Stage-I Audit: Document review in accordance with established operating procedures.
- The audit report is reviewed for the purpose of closing N.C.(Non-conformance) and making a referral to the next stage of auditing, which is Stage 2.
- System and Process Audits in accordance with the requirements of the standard constitute Stage II of the audit (s).
- It is required for the certificate to be issued that the N.C. and observations be closed and that the fees be received in full and final payment.
- Review: In preparation for the closing of N.C., a review of the audit report is carried out.
- Certificate issuing: The certificate is granted for a period of one certification cycle and then expires.
- The surveillance audit is carried out on a regular basis in accordance with the frequency that has been established to ensure that the certified standard is being followed in all respects.
- Audit for Re-Certification: After a three-year cycle, the certification is renewed through the process of auditing the certification.
- Refusal of Certification: Certification can be rejected at several stages during the certification process.
How to Get Good Manufacturing Practices (GMP) in Singapore?
GMP consulting and certification agencies with extensive experience in a wide range of management standards will offer you the guidance you need for GMP certification. They provide advice and certification services for all international standards currently accessible in the market. We have an unblemished track record of achievement in the effective implementation of management systems and the receipt of Audit clearances. The cost of GMP certification in Singapore is always affordable for all of our clients when working with us, which is one of the additional benefits of doing business with us.
What is the best way to find a GMP Consultant in Singapore?
If you are seeking information on how to obtain GMP certification in Singapore, you have come to the correct spot since we are a one-stop solution provider for all of your certification needs. We can assist you with GMP certification preparation as well as audits.
The following services are available:
- General Quality Assurance and GMP compliance problems review.
- Validation of computer-based systems.
- Auditing on a computer’s desktop.
- Facility designs are being reviewed for GMP compliance.
- Supplier agreements are being reviewed.
- Training on Good Manufacturing Practices (GMP).