Pharmaceutical industry certifications are necessary for manufacturers to navigate the highly regulated pharmaceutical industry to ensure safety, quality, and efficacy of drugs and other products.
Do You Know? Pharmaceutical companies on average spend between USD 20 to USD 40 million on regulatory compliance each year. The average cost of compliance is $5.47 million versus an average of $14.82 million for non-compliance. (Source: Xyleme, IBM)
As shown below, pharmaceuticals and medicine are among the most regulated industries in USA.
1. Good Manufacturing Practice (GMP) Certification
What it is:
GMP is a system ensuring products are consistently produced and controlled according to quality standards. It covers every aspect of production, including raw material quality, production facilities, equipment maintenance, staff training, and hygiene. GMP guidelines are designed to prevent errors and contamination throughout the manufacturing process.
Importance:
GMP is mandatory for pharmaceutical companies in many countries and is critical for minimizing risks such as contamination, mix-ups, and manufacturing errors.
GMP certification helps build trust with regulators, healthcare professionals, and consumers by demonstrating that a company adheres to stringent quality controls.
Certifying Bodies:
Various global and national authorities issue GMP certifications, including the World Health Organization (WHO), U.S. Food and Drug Administration (FDA), and other national regulatory agencies.
2. ISO 9001: Quality Management System (QMS) Certification
What it is:
ISO 9001 is another key pharmaceutical industry certification that is globally recognized for quality management systems that emphasize continuous improvement and customer satisfaction. This certification also provides a framework for pharma companies to improve operational processes and ensure consistent product quality.
Importance:
Although not specific to pharmaceuticals, ISO 9001 strengthens the overall quality management framework of a pharmaceutical company by fostering a culture of continual improvement and risk management. This certification can complement GMP standards and help companies streamline their operations.
Certifying Bodies:
Certification is provided by accredited bodies such as SGS, Bureau Veritas, TÜV, and other recognized certification agencies.
3. Halal Certification
What it is:
Halal certification ensures pharmaceutical products adhere to Islamic dietary laws, verifying that ingredients, production processes, and handling comply with halal standards. This certification addresses everything from ingredient sourcing to cross-contamination prevention.
Importance:
Halal certification is arguably the only certification that alone opens access to over 2 billion halal consumers globally. For companies targeting or exporting to Muslim-majority markets in Southeast Asia, South Asia, the Middle East, and North Africa, halal certification is essential to enter market access.
Certifying Bodies:
Bodies such as the American Halal Foundation (AHF), Canadian Halal Bureau (CHB), JAKIM (Malaysia), and other regional certification bodies provide halal certification.
Read More: The Untapped Market For Halal Pharmaceuticals
4. ISO 13485: Medical Devices QMS Certification
What it is:
ISO 13485 is a specialized QMS standard tailored for medical device manufacturers, including those producing drug-device combinations, like inhalers or insulin pumps. It addresses regulatory requirements specific to the medical device industry and emphasizes risk management, quality assurance, and safety throughout the product lifecycle.
Importance:
ISO 13485 ensures that medical devices meet stringent regulatory requirements, facilitating market access in various regions, including the EU, USA, and other key markets. This certification is crucial for companies involved in the development and manufacturing of combination products and medical devices.
Certifying Bodies:
Accredited certification bodies such as BSI and Intertek certify companies to ISO 13485 standards.
5. Pharmaceutical Inspection Co-operation Scheme (PIC/S) Certification
What it is:
PIC/S is an international cooperative arrangement between regulatory authorities that harmonizes GMP standards, guidelines, and training among its member countries. PIC/S membership demonstrates a company’s compliance with internationally recognized GMP standards, enhancing regulatory acceptance across different jurisdictions.
Importance:
Being PIC/S certified means easier access to international markets due to mutual recognition of inspection reports and GMP compliance across member countries. It streamlines the inspection process, reducing regulatory hurdles and costs.
Certifying Bodies:
National regulatory agencies of PIC/S member countries conduct inspections based on PIC/S guidelines. These include agencies like the U.S. FDA, EMA, and other national authorities in over 50 participating countries.
6. Good Distribution Practice (GDP) Certification
What it is:
GDP standards ensure that pharmaceutical products are stored, handled, and transported under conditions that maintain their quality and integrity. GDP guidelines cover areas such as warehousing, transportation, temperature control, and security measures to prevent product degradation.
Importance:
GDP certification is crucial in safeguarding the pharmaceutical supply chain from production to the end consumer, ensuring that products are delivered safely without compromising quality. It helps companies mitigate risks such as theft, contamination, and distribution errors.
Certifying Bodies:
Certifications are issued by regulatory bodies like the WHO, EMA, and national health authorities, ensuring that distributors comply with international standards.
7. Good Laboratory Practice (GLP) Certification
What it is:
GLP is another pharmaceutical industry certification that ensures integrity, consistency, and reliability of non-clinical laboratory data, particularly in safety testing environments. It covers laboratory procedures, data management, and quality controls necessary for the safety evaluation of pharmaceuticals.
Importance:
GLP certification is essential for ensuring that laboratory studies meet regulatory requirements, especially those related to preclinical safety data submitted to health authorities for new drug approvals. It underpins the credibility of data used in regulatory submissions, supporting product safety claims.
Certifying Bodies:
GLP compliance is overseen by the FDA, EMA, and various other national and international regulatory bodies.
8. Hazard Analysis and Critical Control Points (HACCP) Certification
What it is:
HACCP is a preventive system that identifies and controls potential hazards in the production process, commonly used in food and pharmaceutical sectors, especially for dietary supplements and nutraceuticals.
Importance:
HACCP certification ensures that products are safe by systematically controlling hazards that could compromise product safety, such as contamination risks during production.
Certifying Bodies:
Accredited bodies and food safety organizations, such as NSF International, provide HACCP certification.
Check Out: 12 Step Guide for Successful Implementation of HACCP
9. FDA Approval and Certification
What it is:
The FDA approval process involves rigorous testing, inspections, and evaluations to ensure that pharmaceutical products meet safety, efficacy, and quality standards before they can be marketed in the U.S.
Importance:
FDA approval is considered the gold standard globally. It enhances a product’s marketability and credibility, opening doors to various international markets due to the high regard for FDA standards.
Certifying Bodies:
The FDA itself conducts inspections, reviews, and grants approvals.
10. Drug Master File (DMF)
What it is:
A DMF is a confidential document submitted to the FDA, containing detailed information about the manufacturing, processing, and storage of drug components. It supports regulatory submissions by protecting proprietary information while providing the FDA with necessary data.
Importance:
DMFs facilitate the regulatory review process by allowing companies to reference specific manufacturing details without disclosing sensitive information to competitors. It’s essential for companies that supply active ingredients or other components to pharmaceutical firms.
Certifying Bodies:
Managed by the FDA and recognized by other regulatory authorities globally.
Obtain a Quote!
The list of key pharmaceutical industry certifications above provides insights into each certification, highlighting the importance of maintaining high standards of safety, quality, and compliance.
Interested in exploring halal certification for your pharmaceutical facilities and products? Click here to obtain a no obligation quote and free consultation with AHF!
Frequently Asked Questions (FAQs)
Q1. How does Halal certification impact pharmaceutical companies?
Halal certification ensures that pharmaceutical products comply with Islamic dietary laws, covering everything from ingredient sourcing to manufacturing processes. It opens access to over 2 billion halal consumers globally.
Q2. What is the difference between ISO 13485 and ISO 9001 certifications?
A: While ISO 9001 focuses on general quality management across industries, ISO 13485 is specifically tailored for medical devices, including drug-device combinations like insulin pumps. ISO 13485 emphasizes regulatory compliance, risk management, and product safety throughout the lifecycle, making it essential for companies producing medical devices.
Q3. How much do pharmaceutical companies typically spend on regulatory compliance?
A: Pharmaceutical companies spend between USD 20 million and USD 40 million annually on regulatory compliance. The average cost of compliance is about $5.47 million, whereas non-compliance can cost significantly more, averaging around $14.82 million due to fines, recalls, and other penalties.
Q4. What are the consequences of non-compliance with FDA regulations?
A: Non-compliance with FDA regulations can lead to severe consequences, including product recalls, fines, warning letters, and in extreme cases, facility shutdowns. It can also damage a company’s reputation and restrict market access, making compliance crucial for maintaining operations and profitability.
