Practical Approach to Quality and Regulatory Compliance

CEO & Managing Consultant
Sai Pharma Solutions Inc

Many pharmaceutical industries fail to realize that quality and regulatory compliance is more than the job of a single individual or department. For a quality system to be effective, top management needs to establish a systems-based approach in which management at all levels is accountable for achieving business, quality, and compliance success. The system must include clearly defined roles, responsibilities, authorities, and reporting relationships.

Every passing day, the pharmaceutical manufacturers are facing the quality and regulatory compliance issues. Those who were bragging for the quality and regulatory compliance leadership have received warning letters from the regulatory authorities due to critical lapses in their quality systems. Lot many dynamic changes are taking place to meet the compliance requirements. There is hardly any pharmaceutical manufacture that has not faced compliance challenges during the recent past regulatory inspections. Even those having world class facilities and world class documentation systems in place were forced to introspect the loopholes in their existing systems. Traceability, inadequate SOPs, poor documentation, data integrity, risk assessment, training, manipulation, fraudulent practices, lackadaisical approach and impact analysis were such issues which were ignored by the pharmaceutical companies but now time has come for the out of box thinking and resort to quality system transformation exercise. Now it has been well understood that 'Quality' and 'Compliance' come before business.

A lack of uniformity in the responses and the fact that many respondents chose more than one discipline highlights the challenge that organizations face in defining roles, responsibilities, authorities, reporting relationships, and accountability for quality and regulatory compliance. Each firm has its own culture, organization, and performance needs that require cross-functional interactions to manage a compliant quality system. In the past, the accepted practice was for companies to make quality and regulatory compliance the primary responsibility of a specific department or function. However, it has become increasingly clear that firms need to be structured such that management is fully engaged in a transparent and systems -based approach to compliance. In this context the pharmaceutical Industries should stick to the following practices for the consistency of purpose:

1. Identify the responsibilities
2. Create a transparent system
3. Identify the requirements
4. Hold individuals accountable
5. Make compliance and quality everyone's responsibility
6. Translate requirements into practices
7. Accept responsibility
8. Identify the responsible parties
9. FDA and responsible parties
10. Create meaningful job titles
11. Keep top-level management well Informed
12. Empower those responsible
13. Use risk management
14. Less rhetoric and more practices
15. Commit less and do more

'Quality' and 'Compliance' Come Before Business

High levels of quality are essential to achieve company business objectives. Quality, a source of competitive advantage, should remain a hallmark of company products and services. High quality is not an added value; it is an essential basic requirement. Quality does not only relate solely to the end products and services a company provides but also relates to the way the Company employees do their job and the work processes they follow to produce products or services. The work processes should be as efficient as possible and continually improving. company employees constitute the most important resource for improving quality. Each employee in all organizational units is responsible for ensuring that their work processes are efficient and continually improving. Top management should provide the training and an appropriate motivating environment to foster teamwork both within and across organizational units for employees to improve processes. Ultimately, everyone in a company is responsible for the quality of its products and services.

Identifying the Requirements

Compliance is more than just satisfying elements of a regulation or a standard. Top management needs to identify all of the governing requirements that apply to a functioning quality system, including links that exist between regulations and standards, especially the following:Management should also identify those members of the firms management team that would be considered as having the duty and power to act as responsible individuals to take the following three actions:
Detect a failure to meet a specified requirement.
Correct a failure to meet a specified requirement.
Prevent a failure to meet a specified requirement.

If top management of an organization does not establish (define, document, and effectively implement) adequate metrics, it will be unable to determine the true state of compliance or be able to improve the quality system.

Strategic Quality and Compliance Objectives

There is a need for both the industry and regulators to rethink the philosophy behind current approaches toward assessing and establishing quality. A more functional approach would focus on providing greater insight into the state of quality at a given manufacturing facility, allowing stakeholders to better anticipate and address quality issues while simultaneously reducing unnecessary regulatory challenges. Pharmaceutical industries need to understand the following strategic quality and compliance objectives which should be reviewed periodically in order to address the ever -changing compliance requirements because compliance is the 24X7 activity:
Journey of Quality Management System (QC,QA,QMS)
'Quality' and 'Compliance' come before Business
Quality System Approach
Develop adequate and effective SOPs and follow them
Quality by Design
Product Development
Technology Transfer
Quality Risk Management
Change Control
Deviation Management & CAPA
Complaint & Recall Handling
Product Quality Review
Quality Review Meetings
Commitment and Involvement of Management
On-going Stability Programme
ICH Q10 - Pharmaceutical Quality System
21 CFR part 11 and data integrity
Quality Metrics
Pharmaceutical Life Cycle Management
Practical Assessment of Training
One quality voice
Regulatory Expectations
Regulatory harmonization
Surprise Inspections
Controls and challenges to computer systems
Raw data control
Beyond Pharmacopoeia
Impact of non compliances
Quality Culture Index
Good Documentation Practices
Good distribution practices
Process Analytical Technology(PAT)
Contractual Service Management
Vendor Manufacturer and Customer relationship
Casual Approach after Regulatory Approvals
Changing Requirements of Regulatory Submissions
Periodic Review of Validated Systems
Good Engineering Practices and
State of Control
CCTV footage reveals the actual practices followed

Management must take steps to ensure that regulatory and quality compliance is everyone's responsibility.

Learn from the Past Mistakes

The pharmaceutical manufacturers should learn from the past observations of non compliances and should also collect the database of warning letters of other manufacturers in order to review and compare the compliance status of their own facilities and systems with respect to the warning letters. If there is any gap or deficiency, comply it before the audit. The Warning Letter can serve as a tool for improvement of quality and regulatory compliance as it identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company's corrections are adequate.

The Importance of Properly Established and Managed Quality Systems

The importance of properly established and managed quality control and quality assurance systems with their integral well-written SOPs and other quality documents for the achievement of Company business objectives cannot be ignored. They serve as a passport to success by assisting the Company to achieve high-quality processes, procedures, systems, and people, with eventual high-quality products and services and enhancement of the following:
Customer satisfaction, and therefore, customer loyalty and repeat business and referral;
Timely registration of drugs by eliminating waste and the need for rework;
Operational results such as revenue, profitability, market share and export opportunities;
Alignment of processes with achievement of better results;
Understanding and motivation of employees toward the Company quality policy and business objectives, as well as participation in continual quality improvement initiatives; and
Confidence of interested parties in the effectiveness and efficiency of the Company as demonstrated by the financial and social gains from Company performance and reputation


The regulatory burden on the Pharmaceutical and Life Sciences industry has never been more challenging. It has been made more complex by globalization and resultant changes in business models, consumer markets, supply chain and manufacturing. Given the increasing public scrutiny of drug safety, both regulators and Pharmaceutical and Life Sciences companies are feeling the strain of higher reporting volumes and new and ever-changing regulations. The immediate fallout is operational redundancies, reporting backlogs and higher costs. Stringent but evolving regulatory standards have also made compliance more demanding.

Many firms fail to realize that quality and regulatory compliance is more than the job of a single individual or department. For a quality system to be effective, top management needs to establish a systems-based approach in which management at all levels is accountable for achieving business, quality , and compliance success. The system must include clearly defined roles, responsibilities, authorities, and reporting relationships.

Quality department has responsibility for corrective and preventive action (CAPA) management; document control; equipment calibration; external audits; final inspection; incoming inspection of raw material; in-process inspection; internal quality audits; management representative, product, and GMP audits; product complaint management; product releases; process validation; risk management; sterilization; supplier program management; and supplier qualification.
Regulatory Department has responsibility for adverse-event reporting, annual product releases, facility registration and licenses, production registration and certification, product regulatory submissions, and recalls.
Compliance and other departments have responsibility for a business code of conduct, environmental program management, health and safety program management, preventive maintenance, and training.

Achieving business, compliance, and quality success requires more than posting a sign or developing a procedure. It involves the firm's management not only stating its commitment, but also demonstrating it by becoming fully engaged in a process of translating requirements. That includes translating the firm's own policies into practices.

The need of the hour is the harmony between the procedures, practices and paperwork which should be based on real style of working and should be demonstrated at the time of inspection without any excuse or shortcuts. Adopt the practice of learn, de-learn and re-learn and translate requirements in to practices. Because practice makes a man perfect and consistency of purpose opens the doors of success. Change and transformation with the changing requirements is only the key to survival and success.