QMS SOP [QUALITY MANAGEMENT SYSTEM - STANDARD OPERATING PROCEDURE]
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Standard Operating Procedure (SOP) A Standard Operating Procedure (SOP) is a set of written instructions that documents routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. To ensure quality control, all procedures are standardized, So SOPs are integral part of Quality assurance process. Purpose SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. They may describe, for example, fundamental programmatic actions and technical actions such as analytical processes, and processes for maintaining, calibrating, and using equipment. SOPs are intended to be specific to the organization or facility whose activities are described and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations. If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail if they are not followed. Therefore, the use of SOPs needs to be reviewed and re-enforced by management, preferably the direct supervisor. Current copies of the SOPs also need to be readily accessible for reference in the work areas of those individuals actually performing the activity, either in hard copy or electronic format, otherwise SOPs serve little purpose. SOP-Benefits a) The development and use of SOPs minimizes variation and promotes quality. b) SOPs can indicate compliance with organizational and governmental requirements through detailed work instructions and can be used as apart of a personnel training program. c) It minimizes opportunities form is communication and can address safety concerns. SOP-Writing Styles SOPs should be written in a concise, step-by-step, easy-to-read format. Information should not be overly complicated. SOP Process a) Preparation The organization should have a procedure in place for determining what procedures or processes need to be documented. Those SOPs should then be written by individuals knowledgeable with the activity and the organization's internal structure. These individuals are essentially subject-matter experts who actually perform the work or use the process. SOPs should be written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised b) Review and Approval SOPs should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process.
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บริษัท โรงงานเภสัชอุตสาหกรรม เจเอสพี (ประเทศไทย) จำกัด ให้บริการรับจ้าง ผลิตอาหารเสริม, เครื่องสำอาง , อาหารเสริม ,สมุนไพร, ผลิตภัณฑ์เสริมอาหารประเภทวิตามินบำรุงร่างกาย รวมทั้งกาแฟเพื่อสุขภาพ พร้อมขึ้นทะเบียนอาหารเสริมกับองค์การคณะกรรมการอาหารและยา (อ.ย.) ภายใต้แบรนด์ของลูกค้า (OEM) โดยประสบการณ์กว่า 30 ปี ของโรงงาน ผลิตอาหารเสริม ที่ได้รับมาตรฐาน ISO 9001:2008 และมาตรฐาน GMP ควบคุมโดยทีมนักวิทยาศาสตร์ผู้เชี่ยวชาญ. ซึ่งในปัจจุบันได้มีการให้บริการ รับจ้างผลิตยา, รับผลิตอาหารเสริม, ผลิตยาแผนปัจจุบัน, ผลิตยาแผนโบราณ, ผลิตสมุนไพร, รับจ้างบรรจุ ผลิตภัณฑ์เสริมอาหาร ตอกเม็ด บรรจุแคปซูล บรรจุแผงบริสเตอร์ บรรจุขวด ขึ้นทะเบียนยา ทะเบียน อาหารเสริม โดย JSP Pharma เรามีโรงงานผลิตที่พระรามสาม และโรงงานที่ภาคเหนือ จังหวัดลำพูน
Tiêu chuẩn GMP WHO cho các hoạt chất dược dụng
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Regulatory Standards - GMP- Pharmacy.ppt
1. The document discusses key concepts in pharmaceutical quality including GMP, QA, QC, validation, and contamination control. It provides definitions and explanations of these terms.
2. GMP regulations require manufacturers to ensure product quality and safety. The document outlines 17 key parameters that pharmaceutical companies must follow under GMP.
3. Contamination can occur through particulates, chemicals, or microbes. The document describes major sources of each type of contamination and how they can be controlled.
QC QA VALIDATION.pptx
This document discusses quality control, quality assurance, and validation processes in pharmaceutical manufacturing. It defines key terms like QA, QC, cGMP, and describes the three stages of process validation. Quality systems help ensure safety and effectiveness through management responsibilities, resources, manufacturing operations, and evaluation activities. Adhering to cGMP regulations and maintaining a robust quality system leads to consistent production of quality products.
GLP and ISO 9000.pptx
Concepts of GLP and ISO 9000. The Good Laboratory Practices Guideline (GLP) is an FDA regulation. Good Laboratory Practices (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded and reported. National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA). NGCMA was established by the Department of Science & Technology (DST), Government of India, with the approval of the Union Cabinet on April 24, 2002.
ISO 9000 is a series of standards, developed and published by the International Organization for Standardization (ISO), which is an independent, non-governmental organization made up of members from over 160 countries.
The ISO 9000 family of standards is related to Quality Management Systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements. ISO 9000 deals with the fundamentals of quality management systems, including the 7 Quality Management Principles on which the family of standards is based.
good manufacturing practices presentation
This document discusses Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). It defines GMP as ensuring quality standards in drug production and outlines its main principles, including organization, facilities, equipment, materials control, production processes, packaging, and records. SOPs are defined as written instructions for routine tasks and the document discusses benefits like consistent performance, quality assurance, and training. A typical SOP structure is also outlined.
Similar to QMS SOP [QUALITY MANAGEMENT SYSTEM - STANDARD OPERATING PROCEDURE] (20)
Role of quality assurance in pharmaceutical industry
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Master of Good Manufacturing Practice - Course Details
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Pericardium.pptx
The document discusses the benefits of meditation for reducing stress and anxiety. Regular meditation practice can help calm the mind and body by lowering heart rate and blood pressure. Studies have shown that meditating for just 10-20 minutes per day can have significant positive impacts on both mental and physical health over time.
The Heart Anatomy| An Out Look
The heart has four chambers and is located in the chest cavity surrounded by a sac called the pericardium. It has three layers: an inner endocardium, a middle myocardium that is the heart muscle, and an outer epicardium. The heart pumps blood through two circuits, with the left side pumping oxygenated blood through the body and the right side pumping deoxygenated blood to the lungs.
Rheology Study of Flow
rheology
viscosity
newtonian
non-newtonian
plastic
pseudoplastic
dilatant
thixotropy
rheopexy
viscometers
Jl1 drugs and cosmetics act, 1940 and rules part iii part iv
MANUFACTURING OF DRUGS AND COSMETICS
LICENSES
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MANUFACTURE OF NEW DRUGS
Biosensors An analytical Device
Biosensors integrate a biological recognition element with a physiochemical transducer to produce a measurable signal proportional to the analyte concentration. There are several key components of a biosensor including the bioreceptor, transducer, and detector. Common types of biosensors include optical, resonant, physical, ion-sensitive, and electrochemical biosensors. Biosensors offer advantages like specificity, rapid response, and continuous monitoring capability. They have wide applications in fields like medical diagnostics, environmental monitoring, food analysis, and industrial process control.
Coarse dispersions emulsions
Emulsions
Definition
These are homogenous, transparent and thermodynamically stable dispersion of water and oil stabilized by surfactant and co-surfactants
Consists of globules less than 0.1 μm in diameter
Types
Oil dispersed in water (o/w) - oil fraction low
Water dispersed in oil (w/o) - water fraction low
Bicontinuous (amount of oil and water are same)
Advantages
Thermodynamically stable, long shelf life
Potential reservoir of lipophilic or hydrophilic drug
Enhance the absorption and permeation of drugs through biological membranes
Increased solubility and stability of drugs
Ease and economical scale-up
Greater effect at lower concentration
Enhances the bioavailability of poorly soluble drugs
Theories of microemulsion
Interfacial or mixed film theory
Microemulsions are formed spontaneously due to formation of complex film at the interface by a mixture of surfactant and co-surfactant, As a result of which the interfacial tension reduces
Solubilization theory
Microemulsions are considered to be thermodynamically stable solutions of water swollen (w/o) or oil swollen (o/w) spherical micelles
Thermodynamic theory
The free energy of microemulsion formation is dependent on the role of surfactant in lowering the surface tension at the interface and increasing the entropy of the system
Multiple emulsions are complex polydispersed systems where both oil in water and water in oil emulsion exists simultaneously which are stabilized by lipophilic and hydrophilic surfactants respectively
The ratio of these surfactants is important in achieving stable multiple emulsions
They are also known as “Double emulsion” or “emulsion-within-emulsion”
Types
Oil-in-water-in-oil (O/W/O)
An o/w emulsion is dispersed in an oil continuous phase
Water-in-oil-in-water (W/O/W)
a w/o emulsion is dispersed in a water-continuous phase
MONOMOLECULAR ADSORPTION THEORY
MULTIMOLECULAR ADSORPTION THEORY
SOLID PARTICLE ADSORPTION THEORY
ELECTRICAL DOUBLE LAYER THEORY
ORIENTED WEDGE THEORY
Surfactants adsorb at the oil-water interface and form a monomolecular film
This film rapidly envelopes the droplets
They are very compact, elastic, flexible, strong and cannot be easily broken
For getting better stable emulsions combination of surfactants [surfactant blend] are used rather than a single one
The surfactant blend consists of both water soluble and oil soluble surfactants in order to approach the interface from aqueous and oil phase sides
At interface the surfactant blend interact to form a complex and condense a monomolecular film
Ex: A combination of Sodium cetyl sulfate (hydrophilic) and Cholesterol (lipophilic) forms a close packed complex film at the interface that produces an excellent emulsion
Coarse Dispersion Suspensions
Dispersion system
suspensions
interfacial properties of suspensions
zeta potential
Sedimentation parameters
Settling in suspension
Formulation of suspension
Preparation of suspension
Surface and interfacial phenomenon
SURFACE TENSION
INTERFACIAL TENSION
SURFACE FREE ENERGY
DETERMINATION OF SURFACE TENSION
ADSORPTION ISOTHERM
SPREADING COEFFICIENT
DETERGENCY
SOLUBILIZATION
Protein binding factors and significance
factors affecting protein drug binding
significance of protein binding
drug related factors
protein related factors
drug interactions
patient related factors
Polymers of Controlled Drug Delivery System
Polymers
Polymerization
Mucoadhesive polymers
Natural polymers
Synthetic polymers
Smart polymers
ph sensitive polymers
Temperature-sensitive polymers
ion-exchange resin polymers
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diffusion-controlled drug delivery
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JL1 Drugs and Cosmetics Act, 1940 and Rules Part 2
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JL1 Drugs and Cosmetics Act Part 1
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5th Semester B.Pharm Pharmaceutical Jurisprudence
States of matter 2 changes of phases ppt
The document discusses states of matter and changes between different states. It provides information on:
- The three main states of matter - solid, liquid, gas - and how a change of state involves a change in physical form but not chemical identity.
- Energy must be gained or lost for a substance to change states, altering temperature or motion of particles.
- Specific changes include melting (solid to liquid), freezing (liquid to solid), evaporation/boiling (liquid to gas), condensation (gas to liquid), and sublimation (solid to gas).
- Phase diagrams illustrate conditions where states coexist and phase boundaries. Eutectic mixtures have a lower melting point than their components.
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States of matter 1 matter and types converted
The document discusses the three states of matter - solids, liquids, and gases. It describes their characteristics at a microscopic level. Solids have a fixed shape and volume, with particles tightly packed in a repeating pattern that can only vibrate in place. Liquids have a fixed volume but changing shape as particles can move past each other while being attracted. Gases have volumes and shapes that change as particles are always pushing outward and spreading to fill their containers. The document also discusses intermolecular forces such as dispersion forces, dipole-dipole forces, induced dipole forces, and hydrogen bonding that influence the behavior of matter in different states.
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Digital Marketing is a latest method of Marketing techniques widely used across the Globe. Digital Marketing is an online marketing technique and methods used for all products and services through Search Engine and Social media advertisements. Previously the marketing techniques were used without using the internet via direct and indirect marketing strategies such as advertising through Telemarketing,Newspapers,Televisions,Posters etc.
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2. Search Engine Marketing (SEM)
3. Social Media Optimization (SMO)
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Free Website + Digital Marketing Services
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QMS SOP [QUALITY MANAGEMENT SYSTEM - STANDARD OPERATING PROCEDURE]
- 1. QUALITY MANAGEMENT SYSTEM (SOP) MRS. NABEELA MOOSAKUTTY ASST.PROFESSOR, DEPT. OF PHARMACEUTICS K.T.N COLLEGE OF PHARMACY
- 2. Ken Croucher THE BUSINESS INFORMATION MANAGEMENT SYSTEM THAT MANAGES QUALITY POLICIES AND STANDARD OPERATING PROCEDURES 1991
- 3. A SET OF WRITTEN STEP-BY-STEP PROCEDURES OR INSTRUCTIONS THAT MUST BE TAKEN TO PROPERLY PERFORM A ROUTINE ACTIVITY
- 4. 4
- 5. WHERE DO WE START?
- 6. GENERAL REGULATIONS ISO 9001: 2015 Good manufacturing practices Quality System Regulations 6
- 7. SPECIAL REGULATIONS ISO 14971: 2019 – risk management ISO 13485: 2016– quality management 21 CFR 820 – GMP for medical devices 7 Pharmaceutical manufacturers must also consider the processing, packaging and storing requirements listed in 21 CFR 210/211
- 8. 8 FDA LAWS INDUSTRY SPECIFIC CFRs ISO SOPs & WIDs QUALITY MANAGEMENT SYSTEM GMPs QSRs Standard s/Certif. COMPANY / INDUSTRY GOVERNMENT NON-GOVT ORG
- 11. INTERNATIONAL STANDARD THAT SPECIFIES REQUIREMENTS FOR A QMS MOST POPULAR STANDARD IN THE ISO 9000 SERIES THE ONLY STANDARD TO WHICH ORGANIZATIONS CAN CERTIFY PLAN-DO-CHECK-ACT METHODOLOGY PROCESS-ORIENTED APPROACH 11
- 13. 13
- 14. BRIEF EASY TO UNDERSTAND HOW THINGS SHOULD BE DONE RATHER THAN WHAT NEEDS TO BE DONE
- 15. PERFORM RISK ASSESSMENT OBSTACLES RISKS ASSOCIATED WITH OBSTACLES INFORMS THE EMPLOYEE ANY RISKS ASSOCIATED WITH THE PROCESS KEY QUESTIONS WHO PERFORMS WHAT ROLE? WHAT DOES EACH ROLE DO? WHAT’STHE GOAL OR OUTCOME OF EACH PERSON’S ROLE? HAS WHAT NEEDS TO HAPPEN BEEN EXPLAINED CLEARLY? ONCE AN EFFECTIVE SOP WRITTEN ANALYZE UPDATE [EVERY 06 - 12 MONTHS] ANY CHANGE SHOLUD BE RECORDED 15
- 16. 16 1 2 3 DEFINE THE TASK’S GOAL AND UNDERSTAND WHY IT NEEDS AN SOP IDENTIFY TASK DEPENDENCIES DETERMINE FORMAT FOR SOP
- 17. 17 DETERMINE DOCUMENT STRUCTURE – QMS PROCEDURE ELEMENTS • Title • Purpose • Scope • Definitions/Glossary of Terms • Roles, responsibilities and authorities • Definition and listing of data and records • Identification of changes, date of review, approval and version • Main descriptive section • Appendices • References
- 18. 18 SAP S/4HANA Cloud Windchill ETQ Reliance Vault Quality Suite
- 19. THANKYOU MRS. NABEELA MOOSAKUTTY +91 7558019985 connectnabz2021@gmail.com LinkedIn Nabeela Moosakutty