The document provides an overview of the requirements and guidelines for generic drug dossiers using the ASEAN Common Technical Document (ACTD) format. It describes the organization of the ACTD, which contains four parts covering administrative data, quality documents, nonclinical documents, and clinical documents. Part I includes the table of contents, administrative information, and product information. Part II focuses on quality documents for the drug substance and product. Parts III and IV are generally not applicable for generic drugs. The document also lists the types of documents required to complete each part of the ACTD for a generic drug application.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Registration of Indian Drug Product in Overseas Market.pptxNipun Gupta
This includes the following contents:
1. Introduction
2. Procedure for Export of products
3. Technical Documentations
MFR, BMR, COA, COPP
4. Drug Master File
5. Common Technical Document
6. Electronic Common Technical Documents
7. ASEAN Common Technical Document
Since there are many formats of dossier filing, these slides explain in detail about the particular format followed in South East Asian Countries, i.e., ACTD
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Registration of Indian Drug Product in Overseas Market.pptxNipun Gupta
This includes the following contents:
1. Introduction
2. Procedure for Export of products
3. Technical Documentations
MFR, BMR, COA, COPP
4. Drug Master File
5. Common Technical Document
6. Electronic Common Technical Documents
7. ASEAN Common Technical Document
Since there are many formats of dossier filing, these slides explain in detail about the particular format followed in South East Asian Countries, i.e., ACTD
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Role of Business Development in Pharmaceuticals (Generic Product Business)Muhammad Ali Jehangir
Role of Business Development in Pharmaceuticals (Generic Product Business)
For New Updated Slide Deck: https://www.slideshare.net/alijehangir/business-development-licensing-overview-150008616
Overview Drug, Alternative Medicines, Medical Devices Registration in PakistanMuhammad Ali Jehangir
Overview of DRAP requirement regarding Drug Manufacturing And License Fee,Drug Registration and Drug Registration Fee , Drug Pricing, Enlistment and Enlistment Fee, Medical Devices and Medical Devices Fee
Drug Regulatory Affairs By Mr. Pankaj DhapadePankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
REGISTRATION.VN helps you to have an overview of the regulations and procedures relating to registration of the products managed by Vietnamese Ministry of Health (such as registration of foreign companies doing Medicine business, drug registration, quota to import raw materials for medicines, registration for food supplements, cosmetics, medical equipment ...)
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
REGISTRATION OF INDIAN DRUG PRODUCT IN OVERSEAS MARKET.pptxMurthujavali Miper
The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
Demo of Readymade BRC IoP issue 6 Document kit by Global Manager GroupGlobal Manager Group
Global manager group is re-launching its product D114 - BRC Packaging Issue 6 Documentation Kit as per BRC IoP standard requirements.The BRC packaging IoP standard includes some major key changes.The document kit provides with a comprehensive set of pre-written BRC Packaging Issue 6 documents compliant with the newly released BRC packaging IoP standard.For further details you can visit at https://www.globalmanagergroup.com/
The document filing for a pharmaceutical product is done in the form of dossier. The slides explain the format and content to be included in all the formats of dossiers.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
1. Phr_ali91@hotmail.com
Overview of Dossier Requirements and
Guidelines for Generic Product
Muhammad Ali
email: phr_ali91@hotmail.com
ACTD
Asean Common Technical Document
3. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
ACTD
• ASEAN abbreviates Association of South East Asian Nations.
• Established in 08 August 1967
• Ten (10) Member states are Brunei, Cambodia, Indonesia, Lao, Malaysia,
Myanmar, Philippines, Singapore, Thailand, Viet Nam.
• The ASEAN Common Technical Document is organized into four parts. The ACTD
consists of Parts I to IV whereas ICH – CTD has 5 Modules. The administrative data
of Part I is part of ACTD whereas Module 1 of ICH – CTD is purely country
specific. The summaries of the quality (Part II), nonclinical (Part III) and clinical
(Part IV) are located at the beginning of each part of the ACTD. The ICH – CTD
dedicates these summaries in a separate Module 2. As the ACTD does not have
such summary part, it consists of only 4 Parts and not 5.
3Muhammad Ali
5. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
ORGANIZATION OF ACTD
ACTD documents comprises following parts;
PART I: Table of contents, Administrative Data & Product
Information(Applicable)
PART II: Quality Documents(Applicable)
PART III: Non Clinical Documents(Not Applicable for generic products)
PART IV: Clinical Documents(Not Applicable for generic products some exception
may apply)
5Muhammad Ali
7. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
ORGANIZATION OF ACTD….Cont’
Part I : Table of Content Administrative Information and Prescribing Information
Section A: Introduction
Section B: Overall ASEAN Common Technical Dossier Table of Contents
Section C: Documents required for registration (for example, application forms,
labeling, Product Data Sheet, prescribing information)
Part II : Quality Document
Section A: Table of Contents
Section B: Quality Overall Summary
Section C: Body of Data
7Muhammad Ali
8. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
ORGANIZATION OF ACTD… cont’
Part III : Nonclinical Document
Section A: Table of Contents
Section B: Nonclinical Overview
Section C: Nonclinical Written and Tabulated Summaries
1. Table of Contents
2. Pharmacology
3. Pharmacokinetics
4. Toxicology
Section D: Nonclinical Study Reports
1. Table of Contents
2. Pharmacology
3. Pharmacokinetics
4. Toxicology
8Muhammad Ali
9. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
ORGANIZATION OF ACTD….Cont’
Part IV : Clinical Document
Section A: Table of Contents
Section B: Clinical Overview
Section C: Clinical Summary
1. Summary of Biopharmaceutics and Associated Analytical Methods
2. Summary of Clinical Pharmacology Studies
3. Summary of Clinical Efficacy
4. Summary of Clinical Safety
5. Synopses of Individual Studies
Section D: Tabular Listing of All Clinical Studies
Section E: Clinical Study Reports
Section F: List of Key Literature References
9Muhammad Ali
11. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
Generic Guide: Definitions
Active Pharmaceutical Ingredient (API)
A substance or compound that is intended to be used in the manufacture of a
pharmaceutical product as a therapeutically active compound (ingredient)
Pharmaceutical Product
Any preparation for human or veterinary use that is intended to modify or explore
physiological systems or pathological states for the benefit of the recipient.
Finished Pharmaceutical Product (FPP)
A product that has undergone all stages of production, including packaging in its
final container and labelling.
Muhammad Ali 11
12. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
Module 1
Part I contains initially the overall Table of Contents of the whole ACTD to provide
basically the information that could be looked through respectively. Secondly, the
next content is the Administrative Data where required specific documentation in
details is put together such as application forms, label, and package insert etc. The
last section of this part is Product Information where necessary information includes
prescribed information, mode of action, side effects etc.
• Application form1
• Letter of authorization
• Certifications
• Manufacturer License
• GMP Certificate
12Muhammad Ali
14. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
Module 2
• Part II should provide the Overall Summary followed by the Study Reports. The
quality control document should be described in details as much as possible.
S DRUG SUBSTANCE P DRUG PRODUCT
S1 General Information P1 Description and Composition
S2 Manufacture P2 Pharmaceutical Development
S3 Characterization P3 Manufacture
S4 Control of Drug Substance P4 Control of excipients
S5 Reference Standards or Materials P5 Control of Finished Product
S6 Container Closure P6 Reference Standards or Materials
S7 Stability P7 Container Closure
P8 Stability
P9 Product Interchangeability Equivalence evidence
14Muhammad Ali
15. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
Module 2
• Quality overall Summary
• Body of data
• Drug Substance
• General Information
• Manufacture
• Characterization
• Control of Drug substance
• Reference standard or materials
• Container Closure system
• Stability
• Drug Product
• Description and Composition
• Pharmaceutical Development
• Manufacture
15Muhammad Ali
17. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
Module 3…..(Not Applicable)
The document of this part is not required for generic product, minor variation
product and some major variation product. For ASEAN member countries, the study
reports of this part may not be required for NCE, Biotechnological product and some
major variation products. if the original products are already registered and approved
for market authorization in reference countries.
REFRENCE: ACTD Guidelines
17Muhammad Ali
18. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
Module 4…..(Not Applicable)
In the ASEAN region for filing of Generic Drug their main emphasis on
quality document. They permit the official research article related to drug
product in clinical Data and literature references.
REFRENCE: ACTD Guidelines
18Muhammad Ali
19. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
List of Documents Required
List of documents required for Part I Administrative section writing:
1. Application form (details to be filed in)
2. Letter of Authorization
3. Certifications
i. Manufacturing license
ii. Certificate of Pharmaceutical Product
iii. GMP certificate of the Manufacturer
iv. Site Master File of manufacturer
19Muhammad Ali
20. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
List of Documents Required…Cont’
4. Labeling
i. Mock-up for Inner Carton
ii. Mock-up for outer carton
iii. Mock-up for Label
5. Product Information
i. Package Insert
ii. Summary of Product Characteristics (Product Data Sheet)
Summary of Product Characteristics is required for NCE and Biotechnology
products.
iii. Patient Information Leaflet (PIL)
PIL is required for Over-the-Counter Products Product Information
20Muhammad Ali
21. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
List of Documents Required…Cont’
List of documents required for Part II Quality section writing:
1. DMF of API
2. BMR Finished product
3. BPR Finished product
4. Critical manufacturing steps and justifications
5. Process validation protocol and report
6. Flow chart (Detailed and simple)
7. Process development report
8. Impurity profile with justifications
21Muhammad Ali
22. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
List of Documents Required…Cont’
9. Excipient details :
– Specification and testing method
– COA
– TSE/BSE declaration from supplier/manufacturer.
10. Specification and method of Analysis (MOA)
– Intermediates and in-process specification & MOA
– Finished product release specification & MOA
– Finished product Stability specification & MOA
– API specification & MOA from finished product manufacturer.
– Packaging material (primary, secondary and tertiary)
22Muhammad Ali
23. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
List of Documents Required…Cont’
11. Analytical method validations at release and stability (if different methods are used)
– Assay
– Related substance
– Dissolution (if applicable)
– Preservative content (if applicable)
– Sterility (if applicable)
– Endotoxin (if applicable)
– MLT
– Forced degradation
23Muhammad Ali
24. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
List of Documents Required…Cont’
12. COA’s
– API (3 consecutive batches) from FP manufacturer
– All the raw material (excipients and coating materials)
– Reference and working standards
– Impurity standards
– Packaging material (primary, secondary and tertiary)
13. IR spectra of PVC/PVDC sheets and aluminum foil if used
14. Soft copy of labels (PDF)
15. Food grade certificate from primary packaging material manufacturer
for its primary packaging material
24Muhammad Ali
25. Phr_ali91@hotmail.comPhr_ali91@hotmail.com
List of Documents Required…Cont’
16. Preparation of reference standard in brief
17. Stability protocol
18. Stability data and Photo stability data (if applicable)
19. Bioequivalence study (if applicable)
25Muhammad Ali