Understanding Global Regulatory Compliance in the Pharmaceutical Industry

Kazi
Last modified: March 28, 2025

Regulatory compliance in pharmaceutical companies is enforced by regulatory agencies at home and abroad.

Depending on where pharmaceutical sites are located worldwide and where their products are distributed/marketed, each site will need to comply with regulations enforceable by different regulatory agencies.

The regulatory agency will evaluate all sites that take part in the drug product manufacturing.

This oversight includes the range of initial manufacturing steps of the raw materials/APIs to the final packaging sites (primary and secondary). Different regulations are applied depending on the step in the manufacturing process.

An example of this is shown below.

A finished pharmaceutical product that is manufactured in a manufacturing facility and distributed within the US and EU would be required to comply with the regulations of:

i. The Food and Drug Administration (FDA)

ii. The European Union (EU)

The API manufacturing for the above example must also comply with the regulations of the applicable regions.

Q7A Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingredients provides the regulations governing the steps for the Active Pharmaceutical ingredients (API) process.

This post will provide a general overview of the major worldwide regulatory agencies and the regulations they enforce on pharmaceutical companies.

Key Takeaways

The pharmaceutical industry must follow rules from different regulatory agencies, depending on where its drugs are manufactured and sold. Each step in making a drug—from raw materials to packaging- has to comply with the regulatory requirements.
If a drug is marketed in the U.S. and Europe, it must meet the requirements of both the FDA and the EU. These rules ensure that drugs are safe, pure, and effective.
Pharmacopoeias are official books that list drug quality standards. The most recognized ones are from the U.S., Europe, and Japan. Groups like ICH and the Pharmacopoeial Discussion Group help align these standards across countries.
Regulatory agencies such as the FDA, EMA, TGA, and others in Canada and Japan check if the pharmaceutical companies follow the rules. They review new drug applications, inspect manufacturing sites, and monitor safety after drugs reach the market.
If problems arise, these agencies can recall products, update labels, or stop sales. The FDA, for example, inspects both U.S. and foreign facilities and works closely with other countries to ensure standards are met.
The EU follows shared rules among its member countries, which allows the free movement of drugs within Europe. EU inspectors trust one another’s work, and mutual recognition agreements help reduce duplicated inspections.
Australia, Canada, and Japan have their own systems but also work with the U.S. and EU. They’ve signed agreements to exchange information and accept each other’s inspections. This speeds up drug approvals while keeping safety in check.
Many other countries follow WHO guidelines, especially where local regulations are still developing.
Overall, making and selling a drug involves regulatory compliance for pharmaceuticals, sometimes from multiple countries. Global cooperation is growing, and agencies are working together to ensure consistency worldwide

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Roles of Pharmacopoeias in regulatory compliance

Pharmacopoeias are recognized as the official standards for the identity, strength, quality, and purity of pharmaceutical products. They also include Packaging and Labeling guidelines. Compliance with these pharmacopoeias is a big part of regulatory compliance in pharmaceuticals.

The purpose is to guarantee an acceptable quality of the final product by specifying standards for Raw materials, Packaging materials, and Dosage forms (preparations).

The most predominately recognized Pharmacopoeias are the European Pharmacopoeia (Ph. Eur), the US Pharmacopoeia-National Formulary (USP/NF), and the Japanese Pharmacopoeia (JP).

Within ICH, the Working Group “Q4” is responsible for Pharmacopoeias and their harmonization through the three pharmacopeia organizations (USP, JP, and EP).

The three organizations conduct their harmonization efforts through a tripartite pharmacopeia harmonization program, the Pharmacopoeial Discussion Group (PDG).

The ICH Steering Committee has considered the harmonization of about 10 compendial test chapters critical; these chapters are now at various stages of harmonization.

Another important task is to have the “Regulatory Acceptance of Pharmacopoeial Interchangeability”.

The Expert Working Group Q4B works on the following:

a. Facilitate the regulatory acceptance of PDG-harmonized text.

b. Clearly indicate (electronically) the regulatory interchangeability status of harmonized text for each of the regulatory regions, as well as indicate the effective date to begin use on applicable regulatory documents.

c. Ensure that from a regulatory perspective, the interchangeability is based on sound science.

d. Facilitate regulatory and industry access to the “benchmarked” harmonized text, ensuring that everyone is aware of exactly what text has been reviewed and given status for interchangeability. This is deemed essential for the regulatory acceptance of interchangeability.

e. Working with the Pharmacopoeial Discussion Group expedites the implementation for interchangeability.

Worldwide Regulatory Agencies

Regulatory agencies play a very important role in the pharmaceutical business by assuring the public that the products on the market are safe and effective.

Quality and Regulatory Compliance Manuals are to be developed to assure conformance to all major regulatory authorities.

The expectation of a quality product is the same, and the requirements are similar for these agencies. The achievement of quality is managed through different mechanisms.

Quality is determined by the level of regulatory compliance by pharmaceutical firms and makes scientifically justified decisions.

Pharmaceutical companies are now taking a proactive stance with the new GMP Systems approach, more effective internal auditing, and increased regulatory awareness throughout the company.

Quality can only be achieved when everyone works together to meet the challenge.

In the global environment, it becomes even more evident that individuals must understand the major multiple regulations and regulatory authorities that any pharmaceutical company must abide by.

There are still other regulations and regulatory authorities of smaller magnitude throughout the world that need to be considered.

Responsibilities of Regulatory Authorities

Regulatory Authorities have a wide range of responsibilities for medicinal products. The extent may vary, but the most common responsibilities will be described here.

1. New Product Review

A regulatory authority will review applications for new medicinal products, including the results of laboratory, animal, and human clinical testing conducted by companies.

The regulatory authority’s inspectors verify data and GMP compliance. If the regulatory authority determines the product is safe and effective, the company will get approval to sell it.

2. Acting as a “Watchdog”

Once products are on the market, the regulatory authority monitors their manufacture and responds to reports of problems or newly identified risks. This monitoring normally includes laboratory testing of samples.

Because initial testing of products is based on a relatively small number of users, the regulatory authority will monitor reports of adverse events with products after they are marketed.

If this monitoring turns up a problem that needs to be corrected, the regulatory authority can,

i. Ask the manufacturer to recall the product,

ii. Withdraw approval (of a drug, for example),

iii. Require labeling changes, or

iv. Send warnings to physicians or other health practitioners.

3. Standards and Regulations

The regulatory authorities use regulations and product standards as the “yardsticks” that define specific requirements manufacturers must follow to assure product safety and to provide accurate information to health professionals and consumers.

This work is often performed internationally to encourage using the same or equivalent standards.

4. Research

Research activities within the regulatory authorities provide the scientific basis for its decisions and the tools needed to identify and assess risks.

The agency uses its research results to establish standards, evaluate new products, develop test methods and other support for product monitoring, and study emerging risks.

5. Enforcement – Correcting Problems

When a problem arises, regulatory authorities can take several actions to protect public health. Initially, they work with the manufacturer to correct the problem voluntarily.

If that fails, legal action can be taken, including asking the manufacturer to recall a product, seize products, revoke the manufacturing authorization, and/or ask the courts to take legal action.

US Food and Drug Administration (FDA)

The FDA regulates drug products, biologics, medical devices, cosmetics, foods, and radiological products. As the largest of the world’s drug regulatory agencies, it approves all drug products bought and sold in the USA and imported into the U.S.

The FDA consists of administrative, scientific, and regulatory staff organized under the Office of the Commissioner (appointed by Congress) and has several centers responsible for the various regulated products.

The Centre for Drug Evaluation and Research (CDER) and the Centre for Biologics Evaluation and Research (CBER) provide technical advice and experts for ICH work.

How FDA Works?

FDA’s work includes all the elements described for a regulatory authority. Products that the FDA reviews include:

i. New human drugs and biologics

ii. Complex medical devices

iii. Food and color additives

iv. Infant formulas

v. Animal drugs

In 2002, the FDA made more than 18,500 visits to facilities that manage FDA-regulated products. The FDA also has cooperative arrangements with many state and foreign governments, which inspect their facilities, increasing the total number of facilities inspected.

FDA receives more than 400,000 reports of problems a year. If this monitoring turns up a problem that needs to be corrected, the FDA can:

i. Request the manufacturer to recall the product,

ii. Withdrawal approval (of a drug, for example),

iii. Require labeling changes, or

iv. Send warnings to physicians or other health practitioners.

i. Standards and Regulations

The FDA uses regulations and product standards as the “yardsticks” that define specific requirements manufacturers must follow to assure product safety and to provide accurate information to health professionals and consumers.

The FDA works with foreign governments to encourage the safety and quality of imported products by ensuring that foreign standards are equivalent to those enforced by the FDA.

ii. Research

FDA’s research activities provide the scientific basis for its regulatory decisions and the tools needed to identify and assess risks.

The agency uses its research results to establish standards, evaluate new products, develop test methods and other support for product monitoring, and study emerging risks.

iii. Enforcement – Correcting Problems

When a problem arises, the FDA can take several actions to protect public health.

Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, legal actions can be taken, which include asking the manufacturer to recall a product, having federal marshals seize products if a voluntary recall is not done, and detaining imports at the port of entry until problems are corrected.

If warranted, the FDA can ask the courts to issue injunctions or prosecute those who deliberately violate the law.

iv. Current challenges for the FDA

Today, more than ever, the FDA needs to respond to a rapidly changing world. Many obstacles can be overcome if the FDA continues its high consumer protection standards. The most important of these challenges are:

a. Keeping informed about scientific breakthroughs. FDA scientists will need to keep up with rapidly advancing technologies in all product areas.

b. Understanding more sophisticated products. These “cutting-edge” technologies will translate into products with new complexities and risks.

c. Planning for new public health threats. The FDA needs to be prepared to respond rapidly to unexpected health risks, such as tougher strains of antibiotic-resistant bacteria or more dangerous food-borne illnesses.

d. Predicting the impact of international commerce. Monitoring imports and cooperation with foreign regulators will become more important as international commerce grows.

e. Providing consumers with the information they need. Today’s sophisticated consumers and the wide availability of information about FDA-regulated products will challenge the FDA to ensure that consumers get the information they need from the right sources.

f. Reducing risks to public health. The FDA will continue effectively managing product risks throughout their life cycle—from research and development to use/ consumption. Risk management decisions will be supported by rigorous scientific analysis that weighs, when appropriate, the risk-to-benefit profile of the product itself and the risk versus the benefit associated with Agency actions.

The FDA/ORA Guide to International Inspections and Travel is intended to assist in fulfilling the FDA’s overall mission of assuring that drugs, medical devices, biological, and food products manufactured in foreign countries and intended for U.S. distribution comply with the law and regulations, that non-compliance is identified and corrected, and that any unsafe or unlawful products are removed from the marketplace.

This guide provides FDA personnel with standard operation, inspection, and investigation procedures to ensure program uniformity.

It contains instructions and references to assist investigators and analysts who conduct international inspections.

It also provides information regarding authorities, objectives, responsibilities, and policies and guides applicable to inspectional operations, administrative procedures, and the basic guidance for FDA personnel traveling to foreign countries.

This guide is not designed to be all-inclusive nor unduly restrictive. The procedures and guides are intended to supplement investigators’ and analysts’ experience, skill, and proficiency and serve as a reference.

The European Union (EU)

The European Union (EU) is the union of twenty-seven European countries or Member States. The EU is a single market that will allow the free movement of products throughout the EU.

These EU countries, with different histories and cultures, needed to fulfill the economic and political conditions known as the “Copenhagen criteria” to join the EU.

Requirements for membership are that a nation must:

i. Be a stable democracy, respecting human rights, the rule of law, and the protection of minorities.

ii. Have a functioning market economy.

iii. Adopt the common rules, standards, and policies that comprise the body of EU law.

The Parliament, the Commission, and the Council govern the European Union. The decision-making process starts with the Commission’s proposal. Laws/decisions can be passed/taken by the parliament and sometimes the council.

The following commission has been developed within the European Union to ensure drug products’ safety, efficacy, and quality.

European Commission (EC)- Enterprise DG – Pharmaceutical and Cosmetics.

This commission initiates new proposals, whether new legislation or new authorization procedures, monitors implementation by national authorities, and refers infringements to the European Court of Justice.

The Commission’s Directorate General includes a unit responsible for pharmaceuticals and cosmetics. The Commission is responsible for the

EU GMP, which is published on the Commission website. The GMP is continuously updated.

European Medicines Agency (EMEA)

The EU has established a joint regulatory agency in London, originally named the European Agency for the Evaluation of Medicinal Products and is now called the European Medicines Agency (EMEA).

The tasks of EMEA are to:

a. Protect and promote public and animal health

b. Coordinate the evaluation and supervision of medicinal products throughout the European Union using the resources existing in the Member States

All EU member states have their regulatory agencies that provide the inspections necessary under EU regulations. Companies in the EU are required to have Manufacturing Authorizations to manufacture Medicinal Products.

Manufacturing Authorizations are issued by the Member State’s regulatory agency, which also supervises all manufacturing authorizations within its territory. A listing can be found on the Heads of Agency website.

Mutual Recognition Agreements between EU and other countries

In the EU, the Commission has the authority to negotiate Mutual Recognition Agreements with other countries. The European Community (EC) and MRA Partner Countries have established the MRAs to:

a. Reduce technical barriers to trade by facilitating market access while safeguarding consumer interests in health.

b. Grant mutual acceptance of inspection reports, certificates, authorizations, and conformity marks issued by the regulated authorities of the Parties and manufacturers’ declarations of conformity certifying conformity to the requirements of the other Party.

c. Exchange information concerning procedures used to ensure that the conformity assessment bodies comply with the general principles of designation.

d. Encourage greater international harmonization.

Comparison of FDA and EU Practices on Regulatory Compliance

The enforcement actions listed below show differences between the FDA’s and EU’s business practices.

FDA and EU enforcement actions compared relative to increasing seriousness:

FDA	EU
Inspection	Inspection
C observations”/EIR	Post-inspection deficiency letter/report/ manufacturing authorization suspended/revoked.
Warning letter	The escalation letter of potential regulatory action/manufacturing authorization was suspended/revoked.
Recall	Recall
Seizure	Not a formal step – may happen in later stages
Consent decree	No direct equivalent
Injunction	License variation, suspension, or revocation

The quality expectations for the FDA and EU vary in that:

– The FDA does not have a specific regulation requiring internal audits but certainly expects them to occur; the EU-GMP defines expectations for an established audit program.

– The FDA does not mandate a Qualified Person; the EU has a legal requirement of a Qualified Person (QP) also mentioned in the Manufacturing Authorization.

– The FDA believes that the firm, through its Quality System, is responsible for releasing the finished product. The EU and the MHRA believe that a particular person is held legally accountable for ensuring that all quality conditions are met before releasing each batch.

– Another difference is that the US enacted the Freedom of Information (FOI) Statute, which allows the public to access redacted or edited records released to the public or when no further regulatory action is contemplated, whereas the EU does not. However, regulations may differ in the different Member States.

– The level of an inspector’s authority is also different. The EU inspector has a large degree of power and authority.

– An EU inspector may confiscate any material he or she decides should be confiscated at any point during an inspection.

– An inspector can also demand entry to any facility or transportation when he or she has cause to believe that there may be a problem. If needed, an inspector can notify the regulatory head office and immediately suspend a company’s activity or order a recall.

Pharmaceutical Inspection Convention Scheme (PIC/S)

PIC/S is an organization for regulatory authorities. Members must apply for membership and pass a successful evaluation to ensure compliance with the requirements.

PIC/S GMP is equivalent to EU GMP. PIC/S members include health authorities in many countries, including most EU Member States, Switzerland, Australia, and Canada.

Australia / Therapeutic Goods Administration (TGA)

The Australian community expects medicines and medical devices in the marketplace to be safe and of high quality, to a standard equal to that of comparable countries.

The Therapeutic Goods Act 1989, which came into effect on 15 February 1991, aims to provide a national framework for regulating therapeutic goods in Australia and ensuring their quality, safety, and efficacy.

The Australian regulatory framework is based on a risk management approach designed to ensure public health and safety while freeing the industry from any unnecessary regulatory burden.

Any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before the product can be supplied in Australia.

The ARTG is a computer database of information about therapeutic goods for human use approved for supply in or exported from Australia.

The Therapeutic Goods Act, Regulations, and Orders establish the requirements for including therapeutic goods in the ARTG, including advertising, labeling, product appearance, and appeal guidelines.

Some provisions, such as the scheduling of substances and the safe storage of therapeutic goods, are included by the relevant State or Territory legislation.

Cooperative Arrangement between the FDA and the TGA

On October 11, 2000, the TGA signed a cooperative arrangement with the Food and Drug Administration (FDA), USA, regarding exchanging information on current Good Manufacturing Practice (GMP) inspections of human pharmaceutical manufacturing facilities. Under this agreement, the FDA and TGA expressed their intent to:

a. Provide copies of pharmaceutical establishment inspection reports (confidential information purged) and product sample results to one another, upon request, within certain specified time frames.

b. Notify one another when one authority plans to conduct inspections in the other authority’s territory and be receptive to permitting joint inspections for the purpose of promoting better understanding of one another’s inspectional programs and techniques.

c. Provide other GMP-related information such as recall information, adverse product trends, health hazard evaluations, and alert system information.

Both authorities agree to exchange appropriate information about manufacturers when shortage situations occur that involve medically necessary human pharmaceuticals.

The information in the inspection report allows the FDA and TGA to make their own decisions concerning manufacturers’ compliance and appropriate follow-up. Each agency may conduct its own inspections in the other’s territory if it deems it necessary.

The agreement applies to GMP inspections of pharmaceutical facilities, where the inspections are conducted using the current FDA GMP requirements for drugs or the current TGA GMP Code for medicinal products.

The TGA and EU

Australia has an MRA with the EU, which means that the legislation and the way TGA works regarding pharmaceuticals have been assessed and are considered equivalent to the EU system.

The Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002) replaces the Australian Code of Good Manufacturing Practice for Therapeutic Goods – Medicinal Products (August 1990), the Australian Code of Good Manufacturing Practice for Therapeutic Goods – Medicinal Gases (July 1992) and the Investigational Medicinal Products Code of GMP (Annex 13, EC GMP Guide, 1997).

The new Code is based entirely on the international standard Guide to Good Manufacturing Practices for Medicinal Products, PE 009-2, 1 July 2004, published by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S).

The modifications to that Guide and its adoption as the Australian Code of Good Manufacturing Practice were done with the expressed permission of the PIC/S.

It was enacted in August 2003 as the basis for the licensing of all Australian manufacturers of medicinal products.

Canadian Health Products and Food Branch Inspectorate (HPFBI)

When a product is offered for sale in Canada to treat or prevent diseases or symptoms, it is regulated as a drug under the Food and Drugs Act.

Health Canada’s Therapeutic Products Directorate (TPD) is responsible for evaluating and monitoring the safety, effectiveness, and quality of pharmaceutical drugs and other therapeutic products available to Canadians. (Note: Contraceptive drugs are included in Medical Devices.)

In January 2002, a new directive, Drug GMP and Establishment Licensing, replaced the previous 1998 version.

The following section shows the various sections and responsibilities of the Health Products and Food Branch Inspectorate.

Therapeutic Products Directorate (TPD)

This directorate (TPD) is responsible for the regulation of pharmaceutical drugs, medical devices, and other therapeutic products available to Canadians. This includes evaluating and monitoring their safety, effectiveness, and quality.

Biologics and Genetic Therapies Directorate (BGTD)

This directorate (BGTD) is responsible for the regulation of biological and radiopharmaceutical drugs, including blood and blood products, viral and bacterial vaccines, genetic therapeutic products, tissues, organs, and xenografts. This includes evaluating and monitoring their safety, effectiveness, and quality.

Marketed Health Products Directorate (MHPD)

This directorate (MHPD) is responsible for the coordination of consistency of post-approval surveillance and assessment of signals and safety trends concerning all marketed health products.

The MHPD works in close collaboration with other Directorates in the Health Products and Food Branch and with other involved Branches.

The FDA and the Canadian Health Products and Food Branch Inspectorate (HPFBI) share a Memorandum of Understanding (MOU) that allows each party to share inspection reports and product sample test results like those that describe the conformity of therapeutic products or of a facility that manufactures, distributes, wholesales, tests or imports these products, with applicable regulatory requirements.

They also may share Information on facilities registered or authorized in each participant’s country that then market products to the other participant’s country, including facilities that only export their products. These are only a few of the points included in the MOU, which was signed in 2003.

Canada, EU, and TGA

Canada has an MRA with the EU and Australia, which means that the legislation and the way the Canadian authority works regarding pharmaceuticals have been assessed and are considered equivalent to the EU and TGA systems.

Ministry of Health, Labor and Welfare, Japan (MHLW)

MHLW is responsible for improving and promoting social welfare, social security, and public health.

One of its nine bureaus is the Pharmaceutical and Medical Safety Bureau, which includes the Evaluation and Licensing Division.

This division is responsible for reviewing and licensing all medicinal products and cosmetics and acts as the focal point for ICH activities.

World Health Organization (WHO)

Many countries, particularly in Asia and Africa, have adopted the WHO GMP, which is available from the WHO website. The requirements are generally similar but less stringent than those of, for example, the EU GMP.

WHO is focused on Essential medicines, e.g., those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness.

Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.

Implementing the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility.

International Conference on Harmonization (ICH)

Harmonization of regulatory requirements was pioneered by the European Community in the 1980s as the EC (now the European Union) moved toward the development of a single market for medicinal products.

The success achieved in Europe demonstrated that harmonization was feasible. At the same time, there were bilateral discussions between Europe, Japan, and the USA on possibilities for harmonization. It was at the WHO

Specific plans for action began to materialize after the Conference of Drug Regulatory Authorities (ICDRA) in Paris in 1989.

Soon afterward, the authorities approached the International Federation of Pharmaceutical Manufacturer’s Associations (IFPMA) to discuss a joint regulatory-industry initiative on international harmonization, and ICH was conceived.

The birth of ICH took place in April 1990 at a meeting hosted by the European Federation of Pharmaceutical Industries Associations (EFPIA) in Brussels.

Representatives of the regulatory authorities and industry associations of Europe, Japan, and the USA met primarily to plan an international conference, but they also discussed the wider implications and terms of reference of ICH.

The ICH Steering Committee (SC), which was established at that meeting, has since met at least twice a year, with the location rotating between the three regions.

ICH Parties

ICH comprises six parties who are directly involved, as well as three observers and IFPMA. The six parties are the founding members of ICH and represent the regulatory bodies and research-based industry in the European Union, Japan, and the USA.

These parties include the EU, EFPIA, MHLW, JPMA, FDA, and PhRMA. The observers are WHO, EFTA, and Canada, represented by Health Canada. This important group of non-voting members acts as a link between the ICH and non-ICH countries and regions.

ICH is operated via the ICH Steering Committee, comprising six parties plus an IFPMA representative. The EMEA provides technical and scientific support from the EU for ICH activities through the Committee for Proprietary Medicinal Products (CPMP).

The ICH Secretariat, which operates from IFPMA in Geneva, supports the Steering Committee.

Early in the ICH Process, it was agreed that there was adequate international agreement on the technical aspects of Good Manufacturing Practices (GMP) for Pharmaceuticals.

Products and that further harmonization action through ICH was not needed. Recently, however, attention has focused on the need to formalize GMP requirements for the components of pharmaceutical products – both active and inactive.

In November 2000, ICH published Q7a for implementing ‘GMP for Active Pharmaceutical Ingredients’ (APIs). In November 2005, ICH published Q8 (Pharmaceutical Development) and Q9 (Risk Management), also for implementation.

Conclusion

Depending on where the product is manufactured and distributed, there can be more than one set of regulatory requirements that the drug product needs to comply with.

As the pharmaceutical business becomes more global and products are allowed to pass freely between countries, the approach of a worldwide standard is gathering momentum. The

FDA has several agreements with other countries (e.g., Australia and Canada) where they will accept the U.S. inspections instead of performing their own. In Europe, the Member States of the EU accept products manufactured in other member countries.

Inspections are conducted on behalf of the EU instead of each individual country. The EU also has several MRAs with other countries that grant mutual acceptance of inspection outcomes. Drug standards are being harmonized through the ICH.

Author: Kazi Hasan

Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation.

Kazi has worked with several global pharmaceutical companies to streamline production processes, ensure product quality, and validate operations complying with international regulatory standards and best practices.

Kazi holds several pharmaceutical industry certifications including post-graduate degrees in Engineering Management and Business Administration.