Areas Needing Remediation/Assistance

Potential Globepharm Support

Companies frequently do not have an objective understanding of how their current operations relate to the GMP requirements of their country, or of a potential export market.

Regulatory agencies are often under-resourced and/or sometimes regulatory agencies perform poor GMP inspections giving companies a false sense of security regarding their true GMP compliance status. And companies often to not have effective internal audit groups to advise where the company’s operations are deficient from GMP requirements and expectations.

Just because your operations may meet the standards required by your local regulatory agency, does not mean that your facilities and operations meet the requirements of the regulatory agencies in potential export markets.

This is usually Globepharm’s first contact with a client, and is our bread-and-butter service to clients. It is a Globepharm gap analysis that provides the total picture of where a company stands today and where it needs to get to in order to comply with the GMP requirements of a target market – whether your home market or an export market. A Globepharm gap analysis is a top-to-bottom systematic review of your operations to reveal key operational and compliance deficiencies.

Whether the target market is Australia, Canada, the European Union, the United States, or anywhere else, we know the standards and expectations that companies need to meet to satisfy the regulatory authorities, and we know how to cost-effectively and speedily attain these standards.

Our business background provides detailed of current GMP non-compliances and their criticality, but also of the potential cost to remediate (fix) the issues highlighted. Management can perform a thorough cost analysis of the economic viability to attempt to implement remediation to attain the project objective.

A Globepharm gap analysis can review the entirety of your operations, or can concentrate on specific sub-systems, including:Quality Assurance Operations, Facilities and Engineering Infrastructure and Operations, Production and Packaging/Labeling Operations, QC Laboratory Operations, Materials Management Operations

Areas Needing Remediation/Assistance

Potential Globepharm Support

Many companies do not have an organizational structure that will optimize getting to, and successfully getting through, an FDA Pre-Approval Inspection (PAI). Additionally company politics and company history very often impede implementation of effective organization structures

With over 200 clients, over 20 years, Globepharm has seen many different organizational structures – what works and what does not work. We can advise on an optimum organization structure and management team to meet your needs and assure that your operations pass an inspection, first time through.

Because Globepharm is perceived by company staff as “an outsider” with no political axe to grind, our recommendations are often very well received and rapidly implemented.

Areas Needing Remediation/Assistance

Potential Globepharm Support

Many companies need to appoint a project leader to ensure that the project is proceeding on track, and to resolve resource concerns

Globepharm has assisted clients by spending one-two weeks with the company at the project start to derive the total master plan, to determine goals to be reached at specific time points, and to provide basic training in EU compliance expectations (see training options below).

Globepharm then returns to the company on a two – three monthly basis to determine whether the project is on track, and where it might need to be modified. If the project has deviated from the previously agreed path, Globepharm to assist in putting the project back on track.

Areas Needing Remediation/Assistance

Potential Globepharm Support

Many companies have problems that their basic facility design does not meet GMP expectations and need to implement facility renovations to bring them up to current GMP expectations

Globepharm, with its engineering and GMP expertise, can critique the facility design plans.

Clients e-mail the facility layout, the air quality and air pressure differential diagrams, and the people and material flows, to Globepharm where we can, within 24-hours, provide effective critique as to where these plans might be deficient in a follow-up teleconference.

Areas Needing Remediation/Assistance

Potential Globepharm Support

Many companies have equipment qualification protocols that have been written and implemented in a manner that does not serve the company well.

Often equipment qualification protocols and process validation protocols are missing key quality acceptance criteria, and key sampling and testing sections; as such, there is a real danger that under EU inspection the current protocols will not withstand scrutiny.

Globepharm can assist with reviewing key equipment qualification and process validation protocols to ensure that they meet the needs of the tasks they are intended to describe in a GMP compliant manner; and in a manner that will withstand EU inspector scrutiny.

Such a review can be performed by e-mail, with a Globepharm critique being available within 24-hours.

Areas Needing Remediation/Assistance

Potential Globepharm Support

Many companies have conclusions to their qualification and validation reports that are just not supported by the data generated in the studies.

These discrepancies (company wishful thinking) are a key cause of companies failing PAI inspections.

Globepharm can, via e-mail and teleconferences, assist a company’s Quality Assurance group to determine that qualification and validation reports are correct and that correct conclusions have been drawn from the data, such that the reports can withstand FDA/EU scrutiny

Such a critique can be performed by e-mail, with a 24-hours turn-around.

Areas Needing Remediation/Assistance

Potential Globepharm Support

When computer systems are used in a company that impact “quality” decisions, or are impact by GMP (and GCP/GLP) regulations, there is a requirement that the computer system meets the electronic record/signature regulations – 21CFR Part 11 in the United States; European GMPs Annex 11.

Globepharm has extensive experience and expertise in quickly and cost-effectively performing gap analysis of a company’s computer/electronic systems to determine whether the systems comply with 21CFR11/Annex 11.

21CFR11/Annex 11 compliance is one of the most complex compliance assessments that is required of a company, and one where there is a danger of either not being performed well (with attendant compliance risk) or of being over-performed (with attendant costs and time issues)

Areas Needing Remediation/Assistance

Potential Globepharm Support

ICH-Q7A Guidelines “GMPs for Active Pharmaceutical Ingredients (APIs)” has been incorporated into both FDA guidelines and into the EU GMPs as Part II – “Basic Requirements for Active Substances used as Starting Materials”; These GMPs require that API manufacturers be audited by the finished dosage form manufacturer (see EMEA guidance document)

Companies can significantly lower the costs of performing chemical suppler audits, by utilizing the fact that Globepharm is performing client and supplier audits in India about once every two months, and in China about once every three months. Globepharm’s reports can be the basis for company’s QA group (or European QP) certifying that the supplier meets EU GMPs.

Areas Needing Remediation/Assistance

Potential Globepharm Support

Many companies do not have properly organized documentation systems to meet the complex regulatory requirements. Nor, often, do companies have sufficient staff to write, approve and train operators/analysts in all SOPs that will be required to demonstrate the facility operates in a GMP compliant manner, and that operations are “in control”

Globepharm can assist by:

Advising and establishing a sound, effective and compliant documentation system and documentation organization;
reviewing key SOPs to ensure that they meet the needs of the jobs they are intended to describe in a GMP compliant manner. Such a review can be performed by e-mail, with a Globepharm critique being available within 24-hours.

Areas Needing Remediation/Assistance

Potential Globepharm Support

Many companies do not provide sufficient effective training to management and supervisory staff in GMP issues

Globepharm can provide dynamic, effective, GMP training courses in any of the following topics:

• FDA cGMPs for Finished Dosage Form Manufacturers (1 day)
• FDA cGMPs for Manufacturers of Biotechnology Products(1 day)
• FDA cGMPs for Manufacturers of Active Pharmaceutical Ingredients (APIs) (1 day)
• EU GMPs for Finished Dosage Form Manufacturers (1 day)
• GMPs for Cosmetic and Drug Manufacturers (1 day)
• USA and EU GMPs – Total Compliance to two different requirements (1 day)
• Effective GMP Inspection Techniques for Government GMP Inspection Agencies (1 day) [this course is only offered to government inspection agencies]
• Managing the QC Lab in a GMP Compliant Manner (1 day)
• Understanding the requirements of the US and European Pharmacopoeias; similarities and differences (1 day)
• Fundamentals and Essentials of Validation (2 days)
• Good Documentation Practices (1 day)
• Effective Investigations and Corrective Actions (CAPA) (1 day)
• Effective Quality Assurance Auditing (1 days)
• Fundamentals and Essentials of Pharmaceutical Water Systems (1 day)
• Preparing For and Living With 21CFR11 (Electronic Record/Electronic Signature) Regulations (1 day)
• GMPs for Pharmaceutical Development Scientists (1 day)
• GMP Week – an entire week of in-house GMP training, customized with separate sessions for each department.

Over the past 20 years these training programs have been well received by hundreds of companies and thousands of staff

Read more in the sections for In-House training and e-Learning

Areas Needing Remediation/Assistance

Potential Globepharm Support

Companies find that when facing FDA/EU inspectors for the first time, they are not familiar with the expectations of the inspectors; nor are companies familiar with the rights they have during an inspection (there are materials that the inspector has no right to review); nor are companies familiar with what to say and what not to say to inspectors (which can get the client into deep trouble and cause a failure to pass the inspection).

Many companies have found that Globepharm’s presence during FDA/EU’s GMP Pre-Approval Inspections has made the inspection easier and helped guarantee success at the inspection.

Should the company desire, Globepharm is happy to be present during the FDA/EU’s GMP compliance inspection.

Over the past 25 years, we have been present, representing the client, during many FDA/EU Pre-Approval Inspections – managing the inspection to assure a “pass”.

Being present at the PAI can be useful in any of the following ways:

1. we know where the questions are coming from and can predict the directions that the questions are going to, enabling advance thought as how best to answer the potential questions;
   
2. we can be in the ‘back room’ and provide last minute coaching to staff on how to answer the question posed;
   
3. we can focus nightly wrap up sessions to assure that effective damage control is taken;
   
4. we can ‘manage’ the inspection to assure that the everything proceeds smoothly