A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
Good storage and distribution practices may apply to all
organizations and individuals involved in any aspect of the
storage and distribution of all the drug products. Storage
and distribution may involve the complex movement of
products around the world, differences in documents and
handling requirements and communication among various
entities in the supply chain.
Holistic management of risk in temperature controlled shipments – an operatio...ELSCC
Identify and implement proper risk management to ensure both shelf life and quality of products. Developing the right storage conditions and packaging infrastructure in your cold chain.
Similar to Pharmaceutical warehousing - quality assurance -B.PHARMA (20)
Neurohumoral transmission in the C.N.S with special emphasis on Pharmacology of various neurotransmitters. General anesthetics. Alcohols and disulfiram. Sedatives, hypnotics and centrally acting muscle relaxants, Psychopharmacological agents: Antipsychotics, antidepressants, antianxiety agents, anti-manics and hallucinogens. Anti-epileptic drugs. Anti-parkinsonism drugs. Nootropics. Narcotic analgesics, drug addiction, drug abuse, tolerance and dependence.
GPAT-MCQS-SERIES
PART-4
Central Nervous System
GPAT/NIPER/DI EXAMS PREPARATION
PHARMACY
PHARMACOLOGY MEQS
CNS MCQS
endocrine pharmacology. Hypothalamic and pituitary hormones. Thyroid hormones and ant thyroid drugs, Parathormone, Calcitonin and vitamin-D. Insulin, oral hypoglycemic agents and glucagon. ACTH and corticosteroids. Androgens and anabolic steroids. Estrogens, progesterone and oral contraceptives. Drugs acting on the uterus.
: Neurohumoral transmission (Autonomic and somatic). Parasympathomimetics, Parasympatholytics, Sympathomimetics, Sympatholytics, Ganglionic stimulants and blockers. Neuromuscular blocking agents and skeletal muscle relaxants (peripheral). Local anesthetic agents. Drugs used in Myasthenia Gravis.
Gpat mcqs-series part 1 basic pharmacologyJafarali Masi
Introduction to Pharmacology- Definition, scope and source of drugs, dosage form and routes of drug administration. Pharmacodynamics-Mechanism of drug action, Receptors, classification and drug receptors interaction, combined effect of drugs, factors modifying drug action. Pharmacokinetics-Mechanism and principle of Absorption, Distribution, Metabolism and Excretion of drugs. Principles of basic and clinical pharmacokinetics. Pharmacogenetics. Adverse drug reactions. Discovery and development of new drugs-Preclinical and clinical studies. mcqs
gpat
niper
di
Ocular drug delivery system - NDDS - B.PHARMAJafarali Masi
Ocular drug delivery system - NDDS - B.PHARMA
Introduction, intra ocular barriers and methods to overcome –Preliminary study, ocular formulations and ocuserts
Intrauterine drug delivery system - nddsJafarali Masi
novel drug delivery system(NDDS) b.pharma semester 7,
Intrauterine Drug Delivery Systems: Introduction, advantages and disadvantages, development of intra uterine devices (IUDs) and applications
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
1. PHARMACEUTICAL WAREHOUSING
QUALITY ASSURANCE
BP706TT
B.PHARMA SEMESTER 7
jsmasipharmacy.blogspot.com
CONTENT
1. Objective
2. Reason
3. Warehousing procedures
4. Premises
5. Storage Condition
6. Stock management
7. Documentation
8. Inventories
9. Reception of goods
10.Audit
2
1.OBJECTIVE
1. Factory stores will invariably be receiving duly approved raw materials and packaging
materials from third party.
2. A suitable spaceis provided to raw material and packaging materials for manufacturer. this
spaceis known as Warehouse.
3. It is a part of pharmaceutical company.
2.FOR WHAT?
To enable the fastest and cheapest transport of drugs and medical equipment from suppliers to
beneficiaries
2. There are mainly 3 stages:
1. Purchase of pharmaceutical goods.
2. Storage of ordered products .
3. Distribution of stocked products.
3.WAREHOUSING PROCEDURES
1. Quarantine of drug products beforerelease by the quality control unit
2. Storage of the drug productunder appropriate condition of temp.,humidity and light so that
the identity strength,quality and purity of drug products are not affected.
4…PREMISES
Principle : Premises must be located, designed, constructed, adapted, and maintained to suit
the operations to be carried out.
It includes:
Ancillary areas,
Storage areas
Weighing areas
Production areas
Quality controlareas
Sterile areas 6
Storage areas
3. BASIC RULES FOR STORAGE
Systematic storage of the delivered goods.
Use of pallets.
Provision of shelves.
On shelves each productshall have one
specific place.
Prevention of collapses.
Controlled products stored in a lockingcabinet.
Flammable products stored in a separate well ventilated room.
Remove infested,damaged,or outdated goods immediately.
Suspectproducts shall be physically separated from other products stock.
8
WHO GUIDELINES FOR STORAGE AREA
Storage areas should be of sufficient capacity to allow orderly storage of the various
categories of materials and products with proper separation and segregation.
Receiving and dispatch bays should be separated and protect materials and products from
the weather.
Segregation should be provided for the storage of rejected, recalled, or returned materials or
products
Highly active and radioactive materials, narcotics, other dangerous drug and substances
presenting special risks of abuse, or explosion should be stored in safe and secure areas.
There should normally be a separate sampling area for starting materials
5…STORAGECONDITION
A. TEMPERATURE
Daily monitoring and recorded every hour.
Temp. in warehouse must not exceed 25-300 C.
Material that required stored in coolplace should be stored in air condition rooms.
4. B. AIR
All containers should be hermentically closed.
Avoid prolonged unpackage material.
Prefer original packaging to guaranteed airtigthtness and opacity.
Premises should be ventilated.
C. LIGHT
Many API should be stored in dark room.
API should not be directly exposed to sunlight and not to be issued untill and unless it is
required in manufacturing.
6…SHELF LIFE OF THE PRODUCT
A. Expiry Date
The expiration date applies to a drug in its original closed and undamaged package or
container.
It must appear on the package and/or on the product.
If this date is preceeded by <USE BEFORE…>, then the first day of the stated month shall
be set.
B. MANAGEMENT OF OUTDATED PRODUCTS
First, the expired products must be removed from the stock of the products. Stored in a
locked area
Secondly, these products are sorted by form to be destroyed in compliance with law and
regulations.
7….ADDITIONALGENERALREQUIREMENTFOR WAREHOUSING
Clean the premises with disinfectants.
To clean the ground surface regularly.
5. To clear the undergrowth from around the warehouse regularly. Smoking and eating must be
forbidden in the
premises.
Faclility of locking doors and protective windows
To provide extingushers to fight fires.
To fight against pests.
Adapted and functional lighting as well as generators ready to works. 16
8…STOCKMANAGEMENT
Objectives
To ensure continuity of supplies
To avoid over stocking
Stockmanagement will set out to;
monitor stocklevels
monitor consumption
anticipate delivery time for order activation. 19
ISSUING OF MATERIAL
store should issue raw and packaging materials on the basis of FIFO (first come first out)
basis.
Entry and exit of every consignment of materials should be entered on the stockcard.
Issuing of materials should do on the basis of raw and packaging materials required in
manufacturing process.while issuing hazardous and explosive materials, The operation
should be supervised to prevent any mistake.
9…DOCUMENTATION
Stockcard
It is a simple and efficient tool that enables the management of a warehouse.
A stockcard should be created for each pharmaceutical productand regularly updated.They
must be easily accessible
6. It is necessary to
1. Identify stockmovements : incoming and outgoing products
2. Know the theoretical stocklevel at any point in time
3. Monitor the consumption of the different users
4. Monitor expiry dates
5. Assess losses by comparing the theoretical and real stocks
6. Have data to plan subsequent orders. 22
STOCKCARD CHARACTERISTICS
Separate stockcard should be maintained for each consignment
Exact description of the product
Expiry date of the product
Products movements:date;incoming quantities and origin ; outgoing quantities and
destination; losses due to damaged products, brokenflakes, outdated products, lost
products
Stocklevel after every movement
10…INVENTORIES
Inventory makes it possible to check the expiry dates of all the pharmaceutical
products.
It is essential to make an inventory of the quantities that really are in stock(physical
stock)
The inventory should be conducted in a minimum time and the results should
immediately be recorded to enable normal working to resume. 25
11…RECEPTIONOF GOODS
Inspection of an order
A separate rack should be provided to store approved raw and packaging materials.
Materials that is awaiting for approval should be kept in “Quarantine area”.
Quarantine materials should be labeled “Under Test” till it released by Quality control
division.
After receiving approval,it should be taken into stock.
First inspection
7. Collect and check all the documents required for these transports
Count the number of boxes on each pallet and check that it conforms to the number given
by the supplier on the packing list.
Check the condition of boxes : do some of them look to have been endamaged,opened.
Check the special preservation conditions:cold chain 28
27
SECOND INSPECTION
Secondly,the consignment must be checked in full by the medical team should be
Check that the goods delivered do correspond to the invoice;
Check that the quantities received match the quantities shown on the packing list.
Check the conformity of each product:designation,quantity per packing
unit,packaging,labeling,expiry date and productappearance(color change,precipitation
etc)
12…THE WAREHOUSE STAFF
1. The responsible pharmacist
2. The warehouse keeper
3. The warehouse worker
4. The cleaner
5. The security guard
13… QUALITY ASSURANCE
SOPs
Each warehouses will have to establish operating procedures. They must be clearly
defined for each stage activities
Direct purchase from raw materials manufactures
Purchase via Head quarters
Reception of local and imported orders
Unpacking, labeling and storage of products
Computriazed stock managements
Preprations of an orders for delivery
Repacking or ordersf
Returns of drugs
8. Managemenets of outdated drugs
Safety and clenlines of premises
14…AUDITS
Audits aim at assessing the activities and organization of the warehouse.
They aim at answering key questions such likes
Have initially set of activities & quality objectives been reached?
Are procedures correctly written respected,reviewed?
Does the warehouse guarantee for safety standards? 33
REFERENCES
1. Good manufacturing Practices For Pharmaceutics, 4st edi.,Sidney Willing,130- 131.
2. PSF-CIPHARMACEUTICAL GUIDE; How better to manage pharmaceutical warehouses,
March 2003,2-21,27-31.
3. Quality Assurance of Pharmaceuticals; GMP & Inspection;vol.-II.WHO Publication,Pharma
bookSyndicate;28-32.
4. SOP GUIDELINES,D.H. Shah, business Horizons, Pharmaceutical Publishers,2nd reprint
edition,2004,410 34