Role of R&D in Regulatory Filing
Mr. Jayesh H. Jathar
M. Pharm (Research Fellow)
Theme
• Role R&D for regulatory submission
• Supported documents by R&D
– BOM (Bill of Material)
– MFR (Master Formula Record)
– MPR (Master Packaging Record)
– Feasibility Batch Protocol
– Extractable volume and deliverable volume
– Drop size study protocol
– BET and MDD
– PDRF (Product Development Request Form)
– PDR (Product Development Report)
Formulation and Development
• Formulation and development- a concurrent
mode of process development of preparation
and converting into stable and appropriate
dosage form which is acceptable by patient
without in compliance.
OR
• A journey from transformation of drug substance
(i.e. API) into a stable drug product (i.e. dosage
form) called as formulation and development.
Regulatory Affairs (RA) and Role
• A department which helps in protecting a
public health by monitoring safety and
efficacy of product including in area of
pharmaceutical, veterinary, medical devices.
• Regulatory affairs department helps in
obtaining a approval for new pharmaceutical
product from authorized regulatory bodies
for effective distribution and sale of product.
List of regulatory agency
Serial No. Country Regulatory Agency
1. India CDSCO
2. United states of America (USA) USFDA
3. United Kingdom (UK) MHRA
4. European countries EMEA
5. China National Medical Products
Administration (NMPA)
6. Japan Pharmaceutical and medical device
agency (Pmda)
7. Saudi Arabia SFDA
8. South Africa South African Health Products
Regulatory Authority (SAHPRA)
How R&D helps in regulatory submission
• Determine RLD or RS to consider for
development.
• With consideration to RLD or RS,
development started for new product.
• W.r.t. to development, data is generated
and supported to RA.
Bill of Material (BOM)
It includes
• List of drug substances and Excipients
along with pharmaceutical grade,
vendors/ manufacturers and quantity.
• Precautions need to consider while
handling drug substances and excipients.
• List of packaging material along with
vendor/ manufacturers and quantity.
Master Formula Record (MFR)
It includes
• Batch formula,
• List of drug substances
• Excipients
• pharmaceutical grade, vendors/
manufacturers and quantity per ml, per
batch.
Master Packaging Record (MPR)
It includes
• List of packaging material along with
vendor/ manufacturers and quantity.
• Excess quantity are usually mentioned to
effectively use for machine settings.
Feasibility Batch Protocol
Purpose of feasibility batch
• To determine scalability of new under developing product at
manufacturing site.
It includes
• Precautions undertaken during dispensing
• Precautions for Personnel
• Precautions while batch manufacturing to personnel.
• List of active substances and ingredients along with quantity.
• Manufacturing procedure
• Critical process parameters and Critical material attributes.
• Deliverable volume and extractable volume evaluation.
• Sampling Plan
Extractable volume and deliverable volume
• It requires to injectable and ophthalmic
preparation.
• This study done as per USP general chapter
1151.
Contd…
Purpose of Study
• To achieve deliverability of accurate
recommended dose.
• To deliver accurate label dose.
Drop size study protocol
• Specifically recommended for ophthalmic product which
are packed in three piece container.
Purpose of study
• To match with all parameters of RLD.
BET and MDD
1. Bacterial Endotoxin Test (BET)
• Perform as per USP chapter 85.
Purpose
• To compare RLD data with developing
product.
2. Maximum Daily Dose
• Calculated with the help of frequency of
administration in single day.
Product Development Request Form (PDRF)
Purpose
• It’s a preliminary documents required to initiate submission batches at
production.
• Compliance of data were determined by RA.
It includes
• Manufacturing formula.
• Manufacturing procedure.
• Critical attributes.
• Stability study data of atleast 3 months(this study is completed
conducted at R&D).
• Details about packaging material (type of material, vendor).
• Details about overages if used.
• Details about preservatives.
Product Development Report (PDR)
Purpose
• Requires for dossier filing.
It includes
• Manufacturing formula
• Manufacturing procedure
• Stability study data conducted at R&D.
• Stability study data conducted after execution of
submission batches.
• Packaging Material details.
