Frequently asked questions

A Qualified Person (QP) is the legally named individual on a Manufacturer's/Importer's Authorisation (MIA) who certifies that every batch of a medicine has been made and tested in line with GMP and its marketing authorisation before it is released to market. The QP carries personal legal responsibility for that certification under UK and EU law.

A Responsible Person (RP) is the named individual on a Wholesale Dealer's Authorisation (WDA) who ensures medicines are procured, stored, distributed and supplied in line with Good Distribution Practice (GDP). The RP safeguards product quality and supply-chain integrity, and has the authority to act on quality and compliance issues across distribution.

A Responsible Person for import (RPi) is named on a WDA and oversees the importation of licensed medicines into Great Britain from approved countries. The RPi confirms that the required checks, including QP certification or its equivalent in the exporting country, have taken place before the product is placed on the GB market.

A QP is named on a manufacturing licence (MIA) and certifies and releases batches under GMP. An RP is named on a wholesale licence (WDA) and ensures distribution meets GDP. In short, the QP releases medicines and the RP moves and stores them. They are distinct legal roles under different standards.

Both are named on a WDA. The Responsible Person (RP) ensures GDP compliance across all wholesale activities. The Responsible Person for import (RPi) has the specific additional duty of overseeing the importation of medicines into Great Britain and confirming the required import checks. A WDA holder that imports needs both an RP and an RPi.

Yes. One suitably qualified and experienced individual can hold more than one of these roles, provided they meet the eligibility criteria for each and can genuinely fulfil the duties. Many small and virtual companies use a single contract professional acting as QP, RP and RPi to keep oversight consistent and costs proportionate.

A contract QP is an experienced Qualified Person engaged on a day-rate or retainer basis rather than employed full time. They are named on your MIA and certify and release batches, giving you senior QP cover without the cost of a permanent hire. It suits virtual companies, new sites and irregular release schedules.

A contract QP makes sense when your batch volume is low or irregular, when you need cover quickly, during a recruitment gap, or when a permanent senior salary is hard to justify. It converts a fixed cost into a variable one that flexes with output, which is ideal for virtual and first-time pharma companies.

A UK QP must meet the eligibility requirements in the Human Medicines Regulations: a relevant degree, specified subject knowledge across areas such as pharmaceutics, analysis and microbiology, and at least two years of practical batch-release experience. Eligibility is assessed and the individual is named on the MIA, subject to MHRA acceptance.

QP batch certification is the act of a Qualified Person confirming, before release, that a batch has been manufactured and tested in line with GMP, the marketing authorisation and any relevant variations. The QP reviews the batch record and supporting evidence, then certifies the batch in the register. Without certification, a batch cannot legally be sold.

A Manufacturer's/Importer's Authorisation (MIA) is the MHRA licence that allows a company to manufacture, assemble, import and certify the release of licensed medicines. It is held against EU GMP standards and requires a named Qualified Person. A related variant, the MIA(IMP), covers investigational medicinal products used in clinical trials.

A Wholesale Dealer's Authorisation for human medicines (WDA(H)) is the MHRA licence that allows a company to store, distribute, supply and export already-released medicines. It is held against Good Distribution Practice and requires a named Responsible Person. It does not permit manufacture or batch certification, which require an MIA.

An MIA covers making, importing and releasing medicines under GMP and a Qualified Person. A WDA covers storing and distributing already-released medicines under GDP and a Responsible Person. An MIA makes or releases medicines, a WDA moves them. A company that both manufactures and distributes often needs both licences.

It depends on the activity. Importing finished, licensed medicines for wholesale generally needs a WDA with a Responsible Person for import (RPi). Importing in order to manufacture, or to perform QP certification, needs an MIA. The correct route depends on your supply chain and what you do with the product on arrival.

You apply to the MHRA with details of your premises, quality system, named Responsible Person and the activities you intend to carry out. The MHRA reviews the application and conducts a pre-licensing GDP inspection of your site before granting the licence. Strong site and dossier preparation is the difference between a clean grant and delays.

Timelines vary with site readiness and MHRA scheduling, but expect several months from application to grant, including a pre-licensing inspection. The biggest variable is how prepared your site, quality system and named persons are. Thorough readiness work and an independent gap assessment beforehand shorten the path considerably.

Inspection readiness means a working quality system, closed deviations and CAPAs, demonstrated data integrity, current documentation such as a Site Master File, and a team that can host confidently. It is the visible output of a quality system that has worked all year, not something prepared in the final weeks. A mock inspection confirms it.

An MHRA GMP inspection assesses a manufacturing site against EU GMP. Inspectors examine the quality system, deviations and CAPA, data integrity, batch release and QP arrangements, sterile controls where relevant, and premises and personnel. Findings are graded critical, major or other, and you must respond with a time-bound CAPA plan.

An MHRA GDP inspection assesses a wholesale operation against Good Distribution Practice. Inspectors review the quality system, the Responsible Person arrangements, procurement and bona-fide checks, storage and temperature control, transport, returns and recall procedures. As with GMP, findings are graded and require a documented corrective-action response.

Serious findings can lead to conditions on your licence, suspension or, in the worst case, revocation, alongside a deadline to remediate. The usual path is a graded set of deficiencies and a required CAPA plan. A clear, evidence-led response that addresses root cause is the difference between a smooth outcome and escalation.

A GMP audit is an independent assessment of a site, supplier or system against Good Manufacturing Practice. It checks whether the quality system, processes, documentation and controls meet the applicable standards, identifies gaps and risks, and produces a graded, prioritised report. Audits may be internal, supplier-facing or triggered by a specific concern.

A GDP audit assesses a wholesale or distribution operation against Good Distribution Practice. It examines procurement and bona-fide checks, storage and temperature control, transport, returns, recalls and the Responsible Person arrangements. The output is a graded report that helps the organisation close gaps before an MHRA inspection or a customer audit.

A supplier audit evaluates a contract manufacturer, API or material supplier, or service provider against the relevant GxP requirements and your quality agreement. It confirms the supplier can consistently meet quality expectations, qualifies them for use, and feeds your ongoing risk-based audit programme. It is a core part of supply-chain assurance.

A for-cause audit is a targeted assessment triggered by a specific event, such as a complaint, recall, recurring deviation, quality signal or adverse inspection finding. Rather than a routine review, it drills into the issue and the system weaknesses behind it, then defines the corrective actions needed to bring the situation back under control.

A mock inspection is a realistic dry run of an MHRA or FDA inspection, conducted by an independent auditor to the same scope and rigour the regulator would apply. It surfaces gaps while you still have time to fix them and lets your team rehearse hosting under pressure. It is the single most effective inspection-readiness exercise.

Audit frequency should be risk-based rather than fixed. Higher-risk suppliers, such as sterile manufacturers or sole-source API providers, are typically audited more often, while lower-risk suppliers may sit on a longer cycle supported by questionnaires and performance monitoring. A documented risk assessment justifies the interval for each supplier.

A self-inspection is your own internal audit, required by EU GMP Chapter 9, where you examine your own compliance to find and fix gaps. An external audit is conducted by an independent party, either of your site or of a supplier. Both matter: self-inspection drives continuous improvement, external audit adds independent assurance.

An on-site audit is conducted in person, allowing direct observation of the floor, facilities and records. A remote audit is conducted virtually using document review, video walkthroughs and live interviews. Remote audits suit lower-risk reviews and reduce cost and travel, while on-site remains essential for higher-risk and first-time assessments.

A typical GMP audit runs from one to three days on site, depending on the size and complexity of the operation and the scope agreed. Preparation, document review and report writing add to that. A focused supplier audit may be shorter, while a full site or pre-inspection review takes longer.

Audit findings are usually graded by severity, commonly critical, major and minor (or other). A critical finding indicates a significant risk to product quality or patient safety, a major finding a serious gap, and a minor finding a smaller deviation. The grading prioritises remediation so the most important issues are addressed first.

A Pharmaceutical Quality System (PQS) is the overarching quality management framework for a pharmaceutical operation, described by ICH Q10. It links development, manufacturing and distribution under one system covering documentation, deviations, CAPA, change control, risk management and management review, so that quality is built in and maintained across the product lifecycle.

ICH Q10 sets out a model for an effective pharmaceutical quality system across the lifecycle. It requires management responsibility, monitoring of process performance and product quality, CAPA, change management and management review, supported by two enablers: knowledge management and quality risk management. In the EU it sits within GMP as Part III.

CAPA stands for Corrective and Preventive Action: correcting a problem, finding its root cause and preventing recurrence. An effective CAPA addresses the true root cause rather than the symptom, includes a check of effectiveness, and is closed on evidence rather than on a target date. Weak CAPA is one of the most common inspection findings.

A deviation is an unplanned departure from an approved procedure, specification or standard, which is investigated and closed with appropriate action. A change control is a planned, formally assessed and approved change to a process, system or document. In short, deviations are unplanned and reactive, change controls are planned and proactive.

Data integrity means records are complete, consistent and trustworthy across their lifecycle. ALCOA+ describes the attributes of good data: Attributable, Legible, Contemporaneous, Original and Accurate, plus complete, consistent, enduring and available. Inspectors scrutinise audit-trail review, access control and the absence of shared logins as the heart of data integrity.

A Quality or Technical Agreement (QTA) is a written agreement between two parties, such as a marketing authorisation holder and a contract manufacturer, that defines who is responsible for each GMP-related activity. It clarifies roles for areas like release, deviations, changes and complaints, and is a standard expectation in any outsourced quality relationship.

Computer system validation (CSV) is documented evidence that a GxP computerised system performs its intended function reliably and keeps data secure. GAMP 5 is the ISPE good-practice framework that delivers this with a risk-based, lifecycle approach, scaling validation effort to the system's category and risk. It is how you meet EU GMP Annex 11.

21 CFR Part 11 is the US FDA regulation governing electronic records and electronic signatures. It requires controls such as validated systems, secure time-stamped audit trails, access controls, and signatures reliably linked to their records. It is relevant to any company that supplies, or intends to supply, the United States market.

Annex 1 of EU GMP governs the manufacture of sterile medicinal products. The 2022 revision strengthened expectations significantly, placing a formal Contamination Control Strategy (CCS) at the centre, reinforcing quality risk management, and tightening requirements around barrier technology, environmental monitoring and aseptic process design. Sterile manufacturers had to upgrade their controls accordingly.

Quality risk management, described by ICH Q9, is a systematic process for assessing, controlling, communicating and reviewing risks to product quality across the lifecycle. It uses structured tools to identify hazards, evaluate their likelihood and impact, and apply proportionate controls. It underpins decisions throughout the quality system, from validation scope to audit frequency.

Good Distribution Practice (GDP) is the standard governing the procurement, storage, supply, transport and export of medicines. It ensures product quality and integrity are maintained throughout the distribution chain, from the manufacturer to the patient. In the UK and EU it is enforced through the WDA and a named Responsible Person.

Cold-chain or temperature validation provides documented evidence that medicines requiring controlled temperatures are stored and transported within their approved range. It includes temperature mapping of storage areas, qualification of refrigerated equipment and shipping lanes, and monitoring with calibrated devices. It protects temperature-sensitive products and is a core GDP and inspection focus.

Transport validation demonstrates that a shipping route, container or method keeps medicines within their required conditions, particularly temperature, throughout the journey. It involves mapping and qualifying the lane or packaging under representative and worst-case conditions, then monitoring routine shipments. It gives assurance that product quality survives distribution, including across borders.

Every Wholesale Dealer's Authorisation must name a Responsible Person who ensures the operation complies with Good Distribution Practice. The RP must be contactable, suitably experienced, and empowered to act on quality and compliance matters. A WDA holder that also imports medicines into Great Britain additionally needs a Responsible Person for import (RPi).

Qualifying a third-party logistics provider means assessing their GDP compliance before and during use: reviewing their licences and quality system, auditing their facilities and transport controls, agreeing responsibilities in a quality/technical agreement, and monitoring performance over time. The goal is documented assurance that your medicines stay compliant once they leave your control.

Yes. A large part of our work is with small, virtual and first-time pharma companies that need senior quality expertise without a full in-house team. We scope support to your size and stage, from a first MIA or WDA application through to ongoing contract QP, RP or RPi cover, so compliance stays proportionate.

We support quality and compliance across the UK (MHRA), the European Union (EMA and national authorities), the United States (FDA) and the MENA region, drawing on more than twenty years of hands-on experience in those markets. That breadth lets us help companies operating across borders apply the right standard in each jurisdiction.

Yes. We provide named contract Qualified Person, Responsible Person and Responsible Person for import cover on UK and EU licences. The person who reviews your batches and signs the certificate is the senior professional you deal with directly, not a handoff to a junior team. We scope the role to your products and release volume.

Yes. We deliver audits remotely, on site or as a hybrid, chosen to fit the risk and the situation. Remote and hybrid audits reduce cost and travel for lower-risk reviews, while on-site audits remain the right choice for higher-risk, sterile or first-time assessments. We recommend the approach that gives genuine assurance.

It depends on the licence, product and supply route, but we can often onboard quickly to cover an urgent gap, such as the sudden loss of a QP or RP. The first priority is a fast but thorough review of your quality system so certification or distribution can resume on a sound basis, not on trust.