Skip to main content

How to grow your Pharma Business?

  Growing a pharma business requires a strategic approach considering the specific context of your company and the pharmaceutical industry as a whole. Here are some general pointers to get you started: Market and Customer: Identify your target customer: Deeply understand the specific needs and challenges of your target audience, whether it's doctors, patients, hospitals, or other healthcare providers. This helps tailor your products, services, and marketing efforts. Focus on unmet needs: Look for gaps in the market where existing solutions are inadequate or unavailable. Addressing unmet needs can give you a competitive edge and drive innovation. Track market trends: Stay updated on regulatory changes, technological advancements, and emerging diseases to adapt your approach and anticipate future opportunities. Products and Services: Invest in R&D: Develop innovative products or differentiate existing ones through unique formulations, delivery methods, or combinations. Remember
Post a Comment

Schedule M-III

Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule Y


Schedule M-III (Rule 69,69A, 75,75A and 76):
Schedule M-III describes the quality management system for notified medical devices and in vitro diagnostics.
1.       General Requirements
2.       Applicability
3.       Term and definitions
§  Active implantable medical device
§  Active medical device
§  Advisory Notice
§  Customer Complaint
§  Implantable medical device
§  Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly
§  Design inputs means
§  Design output means
§  Design review means
§  Finished device means
§  In-vitro Diagnostic means
§  Management with executive responsibility means
§  Medical device referred
§  Quality audit means
§  Quality policy means
§  Quality system means
§  Rework means
§  Specification means
§  Validation means i)Process validation means ii) Design validation means
§  Verification means
4.       Quality management system
§  General
§  Documentation requirements
·         General
·         Quality Manual
·         Control of documents
·         Control of records
5.       Management responsibility
§  Management commitment
§  Customer focus
§  Quality policy
§  Planning
·         Quality objectives
·         Quality management system planning
§  Responsibility, authority and communication
·         Responsibility and authority
·         Management representative
·         Internal communication
§  Management review
·         General
·         Review input
·         Review output
6.       Resource management
·         Provision of resources
·         Human resources
¨       General
¨       Competence, awareness and training
·         Infrastructure
·         Work environment

7.        Product Realisation
·         Planning of product realization
·         Customer-related processes
¨       Determination of requirements related to the product
¨       Review of requirements related to the product
¨       Customer communication
·         Design and development
¨       Design and development planning
¨       Design and development inputs
¨       Design and development outputs
¨       Design and development review
¨       Design and development verification
¨       Design and development validation
¨       Control of design and development changes
·         Purchasing
¨       Purchasing process
¨       Purchasing information
¨       Verification of purchased product
·         Production and service provision
¨       Control of production and service provision
Ø  General requirements
Ø  Control of production and service provision-Specific requirements
§  Cleanliness of product and contamination control
§  Installation activities
§  Particular requirements for sterile medical devices
Ø  Particular requirements for sterile medical devices
§  General
§  Particular requirements for sterile medical devices
Ø  Identification and traceability
§  Identification
§  Traceability
§  Status identification
Ø  Customer property
Ø  Preservation of product
¨       Control of monitoring and measuring devices
1.       Measurement, analysis and improvement:
·         General
·         Monitoring and measurement
¨       Feedback
¨       Internal audit
¨       Monitoring and measurement of processes
¨       Monitoring and measurement of product
·         Control of nonconforming product
·         Analysis of data
·         Improvement
¨       General
¨       Corrective action
¨       Preventive action


After these provisions and requirements, Drug and Cosmetic act prescribes the annexure for medical devices.

Annexure A: The manufacturer shall prepare a succinct document in the form of Device Master File containing specific information about the device manufacturing in the premises

Annexure B: The manufacturer shall prepare a succinct document in the form of Plant Master File containing specific information about the production and/or control of device manufacturing carried out at the premises.

Annexure C: Environmental requirement for Notified medical devices and in-vitro diagnostics


For more detail refer Drug and Cosmetic Act
लेबल:

Comments

Post a Comment

Ayurvedic Medicine Company

Ayurvedic Medicine Company

Send Distribution/Franchise Query

Name

Email *

Message *

Register your business at

Find pharmaceutical, cosmetics, nutraceutical, ayurveda and alternative medicine's distributors, franchise, suppliers query for free.

If you want to take distribution, franchise or associates with any pharmaceutical, cosmetic or ayush company then you can find it here...

Popular posts from this blog

What are the Schedules under Drug and Cosmetic Act, 1940 & Rules 1945?

Schedules are the set of provisions for classifications of drugs, forms, fees, standards, requirements and regulations related to pharmaceutical, Ayurvedic (including siddha), unani and tibb system of medicines, homeopathy, blood and realted products etc under Drug and Cosmetic Act, 1940 and Rules, 1945. The schedule to the drugs and cosmetics act are Schedule A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y. Drug and cosmetic rules are divided into schedules alphabetically and named also alphabetically like Schedule A, Schedule B etc till Schedule Y. The schedules to the drugs and cosmetics act are important part. Every schedule contains specific information as discussed below. Schedule A:  Schedule A  describes application forms and licenses types. Download Schedule A Pdf Schedule B:  Schedule B  describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories. Download Schedule B Pdf Schedule B1: Schedule B1 describes
2 comments
Read more

How to calculate Price to retailer (PTR) and Price to Stockist (PTS) from any given Maximum Retail Price (MRP)?

Download: PTR/PTS Calculator Download by clicking here You have fixed Maximum Retail price for your product. You have also fixed profit margin, you want to give to retailers, stockists and other distribution channel business partners. But you don’t have knowledge how you can calculate at what price you will bill to stockist and stockist will be to retailers. Then this article is going to be very useful for you...  In this article, we will calculate price to stockist (PTS) and Price to Retailers (PTR) with any given MRP and margin percentage. Also we will provide a PTR/PTS calculator along with how you can make your own PTR/PTS calculator in excel format and we will also provide link to download PTR/PTS calculator in excel. Check related article: profit margin in pharmaceutical industry (Manufacturer to retailers) Have a look at important definitions related to this topic: Distribution Channel: Distribution channel is a group of businesses involved in process of delivery a product/s
3 comments
Read more

Schedule F, F1, F2, F3, FF

Schedules:  Schedule A ,  Schedule B ,  Schedule C ,  Schedule D ,  Schedule E1 ,  Schedule F ,  Schedule G ,  Schedule H ,  Schedule H1 , Schedule I,  Schedule J ,  Schedule K ,  Schedule L1 ,  Schedule M ,  Schedule M1 ,  Schedule M2 ,  Schedule M3 ,  Schedule N ,  Schedule O ,  Schedule P ,  Schedule Q ,  Schedule R ,  Schedule S ,  Schedule T ,  Schedule U ,  Schedule V , Schedule W,  Schedule X ,  Schedule Y Schedule F: Schedule F (Rule 78 and Part X) describes requirements related to Blood and Blood Components. We are describing general heading about schedule. This will give you Idea about schedule structure and matter. Part XIIB: Requirements for the functioning and operation of a blood bank and / or for preparation of blood components. I. This section describes details about Blood Bank and Blood Components General Accommodation for a Blood Bank Personnel Maintenance Equipment Supplies and Reagents Good Manufacturing Practices (GMP’s) and Standard Operat
Post a Comment
Read more