QUALITY CONTROL AND

DRUG REGULATORY
AFFAIRS
CONTENTS
 OVERVIEW OF QUALITY CONTROL IN PHARMACEUTICS
 PRINCIPLES OF GMP AND GMP GUIDELINES
 DOCUMENTATION AND RECORD KEEPING IN QUALITY
CONTROL
 OVERVIEW AND IMPORTANCE OF DRUG REGULATORY
AFFAIRS
 GLOBAL REGULATORY AGENCIES
 DRUG APPROVAL PROCESS
 REGULATORY REQUIREMENTS FOR PRODUCT
REGISTRATION
 REGULATORY CHALLENEGS AND INDUSTRY TRENDS
OVERVIEW OF QUALITY CONTROL IN
PHARMACEUTICS
DEFINITION OF QUALITY CONTROL:
Quality Control (QC) in pharmaceutics refers to the systematic
process of testing and evaluating pharmaceutical products to
ensure they meet the required standards of quality, safety, and
efficacy. This includes the assessment of raw materials, in-
process materials, and finished products to ensure they comply
with predefined specifications.
 Importance of QC
 QC ensures the production of safe, effective, and high-quality
pharmaceutical products.
 It helps to prevent contamination, ensures consistency, maintains
regulatory compliance, and protects public health.
 Effective QC practices minimize product defects, reduce recalls, and
enhance consumer trust in pharmaceutical products.
Responsibilities of QC
 The responsibilities of Quality Control (QC) in pharmaceutics are
critical to ensuring the safety, efficacy, and quality of
pharmaceutical products.
1. Testing and Evaluation
2. Method Validation
3. Documentation
4. Quality Assurance
5. Monitoring Stability
6. Investigating Deviations
7. Calibration of Equipment
8. Compliance with Regulatory Requirements
ISO Guidelines about QC

ISO (International Organization for Standardization)

 ISO standards, such as ISO 9001 (Quality Management Systems) and ISO 13485
(Medical Devices), provide guidelines for establishing effective QC processes in the
pharmaceutical industry.
 These standards focus on continuous improvement, customer satisfaction, and
maintaining compliance with regulatory requirements.
 They help organizations create a structured framework for ensuring quality in every
aspect of pharmaceutical production and distribution.
PRINCIPLES OF GMP
 Good Manufacturing Practices (GMP) are a set of guidelines and
regulations that ensure the consistent production of
pharmaceutical products, food, and medical devices under
controlled conditions.
 GMP focuses on maintaining product quality, safety, and efficacy
through proper design, manufacturing processes, and quality
control measures.
 It involves strict standards for hygiene, equipment, training, and
documentation to prevent contamination and defects.
 Compliance with GMP ensures that products are consistently
produced and controlled according to quality standards.
GMP GUIDELINES
 Good Manufacturing Practice (GMP) guidelines for pharmaceuticals ensure that
medicines are consistently high quality and meet the requirements for their intended
use. GMP guidelines cover all aspects of the manufacturing process, including:

 Product quality: Medicines must be of consistent high quality and meet the requirements
for their intended use.

 Process controls: Robust process controls are important to ensure the consistency and
safety of the manufacturing process.

 Quality management: Quality management helps identify risks, prevent errors, and
guarantee product safety.

 Facility design: The facility design should be correct from the start.
 Procedures: Good procedures should be written and followed.

 Staff: Staff should be trained and developed, and they should practice good
hygiene.

 Records: Good records should be kept.

 Equipment: Facilities and equipment should be maintained.

 Manufacturing process: The manufacturing process should be defined, and critical

manufacturing steps should be validated.

 Premises, storage, and transport: Suitable premises, storage, and transport should
be used.

 Laboratory facilities: Adequate laboratory facilities should be available.

DOCUMENTATION
 Documentation is a systematic procedure of preparation, checking,
verifying, issuing, storing and reviewing of any documents
* It provides necessary working details.

* Reduces the risk of mistake.

* Help in tracing the deviation from the expected yield.

* They help in decreasing the batch-to-batch variation

* Considered as the history of batch operations.

* Self-inspection of procure.
Common type of documents used in pharma industry

Quality
Standard
manuals Batch records operating
procedures

Policies Test methods Stock ledgers

Specifications Log books

RECORD KEEPING
In Quality Control (QC) within the
pharmaceutical industry, a record is a
documented piece of information that
provides evidence of compliance with
procedures, specifications, and regulatory
standards. These records are vital for
ensuring the quality, safety, and efficacy of
pharmaceutical products and for
maintaining regulatory compliance.

TYPES OF RECODS:
1.ANALYTICAL RECORDS
2. SOPS
3. MANUFACTURING RECORDS
4. VALIDATION RECORDS
5. AUDIT AND INSPECTION RECORDS
DRUG REGULATORY AFFAIRS-OVERVIEW
AND IMPORTANCE:
 Drug Regulatory Affairs refers to the field of healthcare that ensures the development,
manufacturing, and distribution of pharmaceutical products comply with laws and regulations. It
involves preparing, submitting, and managing documentation for approval by regulatory
authorities.
IMPORTANCE OF DRA
1. Ensures Safety and Efficacy: DRA ensures that drugs released into the
market are safe for consumption and effective in treating medical
conditions.

2. Compliance with Laws: It helps pharmaceutical companies follow

national and international regulatory requirements.

3. Protects Public Health: By maintaining strict quality standards, it

prevents harmful or ineffective drugs from reaching the public.

4. Facilitates Market Entry: Proper DRA practices accelerate drug

approvals, allowing timely access to essential medicines.

5. Promotes Innovation: By providing guidelines, DRA encourages the

development of new and improved therapies.
ACTIVITIES OF DRA
Core Activities:

o Preparation and submission of drug

applications to regulatory bodies like the
FDA (USA), EMA (Europe), CDSCO
(India), etc.

o Handling queries and approvals related to

clinical trials, manufacturing, labelling,
and marketing of drugs.

o Ensuring that all drug-related

documentation complies with regulatory
standards.
 GLOBAL REGULATORY AGENCIES

Global regulatory agencies play a pivotal role in ensuring

the safety, efficacy, and quality of pharmaceutical
products. These organizations establish guidelines,
enforce regulations, and monitor compliance to protect
public health. They oversee the entire lifecycle of
pharmaceutical products, from clinical trials to post-
market surveillance. The dynamic pharmaceutical
industry relies heavily on these agencies to maintain
standards and foster innovation while ensuring consumer
trust.
DRUG APPROVAL PROCESS:
 The drug approval process ensures that new pharmaceutical products are safe, effective, and of high quality before
reaching the market. This rigorous procedure is governed by drug regulatory affairs, which evaluate the drug's benefits
and risks to ensure public health. Each country has its regulatory body, such as the FDA (USA), EMA (Europe), or
CDSCO (India), overseeing this process.

 Objectives of Drug Approval Process

1. Safety and Efficacy: To confirm that the drug is effective for its intended use and does not pose significant risks.

2. Quality Assurance: To ensure consistent production of high-quality pharmaceuticals.

3. Regulatory Compliance: To align with national and international standards.

4. Public Health Protection: To minimize adverse effects and maximize therapeutic benefits.

5. Market Authorization: To provide a legal framework for drug commercialization.

 Drug
Discovery Investigational New New Drug
and Application
Preclinical Drug(IND)
(NDA)
Research Application Submission

PROCESS OF DRUG APPROVAL

Post-Marketing Approval or Regulatory

Surveillance Rejection Review
REGULATORY REQUIREMENTS FOR PRODUCT
REGISTRATION
 Process of Product Registration

Pre-Submission Preparation: Post-Approval Compliance:

o Compile necessary documents, Regulatory Review: o Continuous monitoring of

including manufacturing safety and periodic updates to
details, preclinical and clinical o Authorities evaluate data for regulatory bodies.
data, and labelling safety, efficacy, and quality.
information.
o Clarifications or additional
o Confirm compliance with data may be requested.
specific country guidelines.
Approval or Rejection:
Dossier Submission:
o If approved, the product
o Submit a registration dossier, receives marketing
often in a common format like authorization.
CTD (Common Technical
o Rejected applications require
Document).
revisions for resubmission.
REGULATORY CHALLENGES AND PHARMA INDUSTRY
TRENDS IN INDIA
 Complex Regulatory Framework

 Overlapping responsibilities of agencies like CDSCO and state authorities create confusion and delays in approvals.

Quality Compliance Issues

 Ensuring adherence to global standards like USFDA and EMA while addressing frequent quality lapses is a persistent
challenge.

Stringent Clinical Trial Regulations

 Delays and high costs in approvals, coupled with global competition, hinder India's competitiveness in conducting clinical
trials.

Drug Pricing and Accessibility

 Stringent price control measures by NPPA impact profitability and discourage investment in innovative drug development.

 Counterfeit Drugs and Enforcement Gaps

 Weak enforcement mechanisms against counterfeit and substandard drugs affect market credibility and public health.
CONCLUSION
 The practice school project work on eight modules focusing on Quality
Control and Regulatory Affairs in the pharmaceutical industry was an
enriching experience. It offered us the opportunity to delve deeply into critical
topics such as regulatory standards, quality assurance practices, and
compliance mechanisms essential for the pharmaceutical sector. We gained
excellent insights into maintaining high-quality standards, ensuring patient
safety, and adhering to global regulatory requirements. This exposure has
significantly enhanced our knowledge and skills, preparing us to meet the
industry's challenges with confidence. Overall, the learning journey was
highly informative and will undoubtedly contribute to our professional
growth.
REFENCES
1. United States Pharmacopeia (USP) 1. Pharmaceutical Sciences and Technology Textbooks

o The USP provides comprehensive standards for pharmaceutical quality,

including quality control tests for various drug products. o Books like "Pharmaceutical Quality Control" and "Pharmaceutical
Analysis" (by authors like P. D. Sethi and H. A. R. E. Lindon) are excellent
o Website: USP
resources for understanding the testing methods and regulations in the

2. International Conference on Harmonisation (ICH) Guidelines pharmaceutical industry.

o The ICH provides guidelines like ICH Q6A and Q6B that detail quality  "Global Pharmaceutical Regulatory Affairs" by James S. Grattidge and Phillip H. A. D. S.
control testing for pharmaceuticals.
O'Sullivan

o Website: ICH This book provides an overview of regulatory systems across different countries and
regions, focusing on regulatory strategies for global markets.
3. Good Manufacturing Practices (GMP) by WHO
 "Pharmaceutical Regulatory Affairs: A Global Perspective" by R. S. S. V. Raghavan
o The World Health Organization offers guidelines on quality control This reference book covers a wide range of topics in regulatory affairs, including
processes as part of GMP for pharmaceuticals.
guidelines, regulatory submissions, and processes for drug development and marketing.

o Website: WHO GMP Guidelines

4. "Pharmaceutical Quality Control" by S. R. Pathak

o This book provides an in-depth analysis of pharmaceutical quality

control tests, methodologies, and applications in the industry.