Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
Herbal medicines are popular because of experience and the abundant
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proven medicinal value.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...ICHAPPS
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As per FDA , Validation is establishing documented evidence, which provides a high degree of assurance that a specific process will produce a product meeting its pre determined specification & quality attributes.
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...ICHAPPS
TRAINING PROGRAMME ON
21CFR PARTS-210 AND 211
QUALITY ASSURANCE
Slideshow About 21 CFR
“Every product must be fit for its intended purpose”
“Every product must be fit for its intended purpose”
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES - UNITED STATES OF AMERICA
ICH guidelines for validation Of Equipments by Nikita Sahu[1].pptxNikitaSahu39
VALIDATION- As per WHO,
Validation means providing documented evidence that any procedure, process, activity or system actually leads to the expected results.
As per FDA , Validation is establishing documented evidence, which provides a high degree of assurance that a specific process will produce a product meeting its pre determined specification & quality attributes.
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Approval page and table of contents.
Introduction and objectives.
plant and process description.
personnel, planning and scheduling.
responsibilities of committee members.
process control aspects.
equipments and apparatus.
process and system.
acceptance criteria.
documentation.
sops .training requirements.
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The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
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Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
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Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
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3. DEFINITION
• A site master file is a document prepared by the manufacturer
containing specific and factual GMP information about the
production and/or control of pharmaceutical manufacturing
operations carried out at the named site and any closely
integrated operations at adjacent and nearby buildings.
• A site master file or SMF is a document in the Pharmaceutical
Industry which provides information about the production and
control of manufacturing operations. The document is created
by a manufacturer e.g., analysis, packaging
4. BENEFITS OF SMF
• SITE MASTER FILE (SMF) provides a general overview of
the site and its operations.
• The Site Master File concept has been developed by PIC/S and
has become a standard expectation of inspectors.
• Pharmaceutical manufacturing activities at the site
• Type of product manufactured at the site
• Employees detailes
5. CONTENTS OF SMF
• It shall contains the following:-
• 1) General information:-
• (a) Brief information of the firm
• (b) Pharmaceutical manufacturing activities as permitted by
the licensing authority
• (c) Other manufacturing activities, if any, carried out on the
premises
6. • (d) Type of products licensed for manufacture with flowcharts
mentioning procedures and process flow
• (e) Number of employees engaged in the production, quality
control, storage and distribution
• (f) Use of outside scientific, analytical or other technical
assistance in relation to manufacture and analysis
7. • (g) Short description of the Quality Management system of the
firm
• (h) Products details registered with foreign countries.
8. • 2) PERSONNEL REQUIREMENT
• (a) Organizational chart showing the arrangement for quality
assurance including production and quality control
9. • (b) Qualification, experience and responsibilities of key
personnel
• (c) Outline for arrangements for basic and in-service training
and how the records are maintained
• (d) Health requirements for personal engaged in production
• (e) Personnel hygiene requirements, including clothing.
10. 3. PREMISES
• (a) Simple plan or description of manufacturing areas drawn to
scale
• (b) Nature of construction and fixtures / fittings
• (c) Brief description of ventilation systems. More details
should be given for critical areas with potential risk of
airborne contamination (schematic drawing of systems)
• Classification of the rooms used for the manufacture of sterile
products should be mentioned
11. • (d) Special areas for the handling of the highly toxic,
hazardous and sensitizing materials
• (e) Brief description of water systems (schematic drawings of
systems), including sanitation
• (f) Description of planned preventive maintenance programs
for premises and of the recording system.
12. 4.EQUIPMENT
• (a) Brief description of major equipment used in production
and quality control laboratories (a list of equipment required)
• (b) Description of planned preventive maintenance programs
for equipment and of the recording system
• (c) Qualification and calibration including the recording
systems and arrangements for computerized systems
validation.
13. 5. SANITATION
• Availability of written specifications and procedures for
cleaning manufacturing areas and equipment.
14. 6. DOCUMENTATION
• (a) Arrangements for the preparation, revision and distribution
of necessary documentation for the manufacture
• (b) Any other documentation related to product quality that is
not mentioned elsewhere (e.g. microbiological controls about
air and water)
15. 7. PRODUCTION
• (a) Brief description of production operations using, wherever
possible, flow sheets and charts specifying important
parameters
• (b) Arrangements for the handling of starting materials,
packaging materials, bulk and finished products, including
sampling, quarantine, release and storage
16. PRODUCTION
• (c) Arrangements for the handling of rejected materials and
products
• (d) Brief description of general policy for process validation.
17. 8. QUALITY CONTROL
• (a) Description of the Quality Control System and of the
activities of the Quality Control Department. Process for the
release of printed components and finished goods
• (b) Procedure for release of Finished Goods
• (c) Procedure for release of printed packaging material
18. 9. Loan license manufacture and licensee
• (a) Description of the way in which compliance of Good
Manufacturing Practices by the loan licensee shall be
assessed.
19. 10. DISTRIBUTION, COMPLAINTS AND
PRODUCT RECALL
• (a) Arrangements and recording system for
distribution
• (b) Arrangements for handling of complaints and
product recalls.
