GROUP MANUAL IN

MANUFACTURING PHARMACY INTERNSHIP

PITAHC – Cagayan Valley Herbal Processing Plant

Department of Pharmacy
Saint Louis University- School of Natural Sciences

Submitted by:
Hawari, Ramsey Ibrahim Z. – 0748: Ma. Adeline G. Antonio, RPh, MSPharm
Latoza, Adriane Paul P. – 0754: Mary Grace Biagtan, RPh, MSPharm
Alili, Rennalyn A. – 0750: Mary Luz C. Fiangaan, RPh, MSPharm
Bagiw, Herchzel Jahayne B. – 0752: Jennylyn P. Gallito, RPh, MSPharm
Bawa-an, Janine Arriane M. – 0756: Ma. Adeline G. Antonio, RPh, MSPharm
Camhit, Mary Grace B. – 0756: Ma. Adeline G. Antonio, RPh, MSPharm
Endrano, Alea Grace B. – 0756: Ma. Adeline G. Antonio, RPh, MSPharm
Feliciano, Jerelyn T. – 0748: Ma. Adeline G. Antonio, RPh, MSPharm
Kollin, Marah Mayette P. – 0756: Ma. Adeline G. Antonio, RPh, MSPharm
Lagman, Elizabeth Porsha B. – 0748: Ma. Adeline G. Antonio, RPh, MSPharm
Pedro, Eden Keith L. – 0748: Ma. Adeline G. Antonio, RPh, MSPharm
Valera, Simonie P. – 0748: Ma. Adeline G. Antonio, RPh, MSPharm

August 12, 2016

 INTERNSHIP MANUAL

IN

MANUFACTURING PHARMACY

Department of Pharmacy
Saint Louis University- School of Natural Sciences
Revised Edition April 2012

INTRODUCTION
 This Internship Manual in Manufacturing Pharmacy embodies the vision of the Department of
Pharmacy of the Saint Louis University- School of Natural Sciences, in association with the Philippine
Association of the Colleges of Pharmacy (PACOP). This output was put together in order to ensure the
effective implementation of the Pharmacy Internship Program and harmonize the efforts of all
academic institutions to produce globally competent pharmacists of the future. Likewise, the SLU
Pharmacy Internship Program specifically in Manufacturing Pharmacy, intends to prepare their
students through actual observation and hands-on experience related to the Industrial practice of

pharmacy, besides being a requirement for the completion of the BS Pharmacy course.

In general, internship is a supervised practical experience required for licensure as a registered

pharmacist. It is intended to provide Pharmacy students with the knowledge and the practical know-
hows necessary for functioning competently and effectively upon licensure, in preparation for careers
in the manufacturing practice. A preceptor is an assigned registered pharmacist working at the site of
internship, of good moral character and qualified to direct the approved experience to be provided to
the intern. The preceptor may serve for more than one intern and is expected to report and evaluate
the progress of the intern as required in the internship program. It is also his/ her duty to expose the
intern to all aspects in the manufacturing set-up, through proper orientation at the start of the
internship, up to supervision of assigned tasks all throughout the period of internship. An evaluation
form will be completed by the preceptor to assess the capability of the intern to follow instructions and

inculcate the principles of Good Manufacturing Practice.

The intern must complete two hundred (200) hours of manufacturing internship and be
accordingly enrolled to proceed. It is intended to allow the intern to explore the Industrial Practice of

Pharmacy.
 MANUFACTURING INTERNSHIP

Manufacturing Pharmacy is a venue where interns are given the chance to practice and observe
a highly specialized area of pharmaceutical analysis. This internship provides the interns an exposure to
the important aspects of manufacturing laboratory works, quality control measures, actual production

and handling of materials, and research and development.

Specifically, the Internship program seeks to:

1. Develop proficiency in operating sophisticated equipment in drug assay procedures.

2. Acquire competence in all aspects of drug testing.
3. Acquire knowledge in product manufacture including labeling and packaging.
4. Inculcate a research- oriented culture among interns.
5. Develop eagerness, awareness and appreciation of the manufacturing processes necessary to
make the drug products.

The various activities included in this manual will serve to guide the interns to enhance their
skills and competency in the actual Manufacturing Pharmacy Practice. As requirement in the Bachelor
of Science in Pharmacy curriculum, this exposure should also be able to provide lifelong reflections
and realistic presentations of how drugs are manufactured. On a personal note, the author wishes the
intern to take the internship seriously enough to learn in an environment where he/ she can possibly

see himself/ herself working in. A bright future in the Industrial Pharmacy practice awaits him/ her.

M. A G. Antonio, RPh.
Internship Adviser
 Activity No. 1

THE INTERN

Objectives:

At the end of this activity, the student is able to:

1. Subject oneself to the Internship Orientation set and prepared by the manufacturing company upon arrival.
2. Prepare for the different activities lined up to complete the internship program.
3. Learn the necessary attire, conduct and expectations required of him/ her during the entire period of stay in the manufacturing company.

Procedure:

A. Group

1. List the different requirements that were asked to be submitted prior to the actual internship date.
 Bio-data
 Medical certificate
 Training fee (1500.00 pesos)
 Plant indigenous to your place
 Memorandum of Agreement
 Recommendation Letter
2. Enumerate and describe the following, as discussed during the internship orientation:
a. Proper attire
Regarding proper attire, it is a must to always wear your lab gowns, head cap, face mask and lab shoes while inside the
production area and QC areas to prevent contamination of samples being tested and ingredients being used. In regards to other
areas of the manufacturing site, you can wear your white shirts and jeans since it would be a more comfortable attire due to the
hot weather.

b. Manner of evaluation of the intern

The intern would be evaluated according to his/her performance inside the manufacturing site and in accordance to the three
different areas they are assigned, namely Bio-assay, Quality Control, and Production areas, also in accordance to the comments
that the staff has regarding the interns attitude and performance.

c. Name and position of supervising personnel

Personnel that would be in charge in supervising the interns regarding their daily activities and their assignments to the different
areas of the manufacturing firm would be Ma’am Carmen B. Valera, RPh, and Marketing specialist.

d. Inclusive dates of internship

The intern’s inclusive dates for internship will be July 7, 2016 to August 10, 2016.
 Activity No. 2

THE ORGANIZATION

Objectives:

At the end of this activity, the student is able to:

1. Familiarize himself with the different levels of management , positions and divisions of the manufacturing company.
2. Discuss the functions of each department and position.

Procedure:

A. Group
1. Attach or illustrate the organizational chart of the manufacturing company showing the levels of management and the different departments
of the same. Include names and positions of personnel if available.
2. Describe the main function/s of the following departments from a series of personal interviews from concerned personnel. Please include
their names and job designations.
a. Production
To produce the right amount of product at the right time and at the right condition. Aims and functions of production
department. Production is the functional area responsible for turning inputs into finished outputs through a series of production
processes. The Production Manager is responsible for making sure that raw materials are provided and made into finished goods
effectively.
- Dr. Abellardo Bas-ong, Veterinarian
b. Quality Control
 Approve or reject all procedures, specifications, methods, and results.
 Approve or reject all raw materials, packaging materials, labeling and finished products.
 Review all production records for accuracy and completeness before approving for distribution.
 Establish procedures for revising procedures, formulas, etc.
 Approve changes to procedures, formulas, etc.
 Ensure that the latest revision is being used at all times.
 Perform all the required tests to ensure identity, purity, potency and composition, and to esnure that products are not
contaminated or adulterated.
- Dr. Abellardo Bas-ong, Veterinarian
c. Warehouse
 Receiving procured materials and items, ensuring they match the purchase order specifications, and applying receipt and storing
procedures
 Storing materials and items as per applied storing rules, and maintaining them from fire or damage
 Delivering the materials and items, after completing the applied regulations, and filling and packing them for shipping
 Monitoring stock level, and reporting the items that have reached the replenish level
 Organizing and maintaining cards and forms, recording materials and items activities, and entering the information into the
system
 Preparing monthly statements of materials and items activities
- Dr. Abellardo Bas-ong, Veterinarian
d. Research and Development
 Do investigational works in various fields .
 The functions of a research and development department are to engage in new product research and development, existing
product updates, quality checks and innovation. The functions of this department are closely related to the functions of the
sales, production and other divisions, requiring collaboration. The department is crucial in developing new products that are
competitive in the market through extensive product and market research.
- Dr. Abellardo Bas-ong, Veterinarian
 Activity No. 3

CURRENT GOOD MANUFACTURING PRACTICES

Objectives:

At the end of this activity, the student is able to:

1. Identify the GMPs applied in the different areas of the manufacturing company.
2. Determine the application of GMPs in the actual plant set-up.

Procedure:

A. Group
1. Enumerate at least THREE important GMPs regarding the following:
a. Buildings and Facilities
i. Production
 The processing of materials for drug products shall be separated from
the production of non-drug products.
 Toilets should not be opened directly to production areas and shall
have adequate supply of water and ventilation.
 Interior surfaces (walls, floors and ceilings) shall be smooth, free from
cracks and open joints, shall not retain or shed particulate matter, shall
permit easy cleaning and disinfecting. The floor in processing areas
shall be made of impervious materials, laid to an even surface, shall
allow prompt and efficient removal of any spillage. Walls shall be of
impervious and washable surface. The coving of junctions between
walls, floors and ceilings in critical areas is necessary.
ii. Quality Control
 The laboratories shall be physically separated from the production rooms. Biological, microbiological and
chemical laboratories shall be segregated from each
other. Air handling facilities for biologicals and
microbiologicals should be separate from process air
handling facilities.
 Provisions shall be made for the proper and safe
storage of waste materials awaiting disposal. Toxic
substance and inflammable materials shall be stored in
suitably designed and storage.
 A separate room shall be provided for instruments to
protect these against electrical interference, vibration,
contact with excessive moisture and other external
factors or where there is need to isolate the instrument.
iii. Warehouse
 The storage and distribution of drug products shall be documented. The most important documents in this
area are inventory card and distribution record.
 Inventory Card
 An inventory card for each product shall be prepared. The card
contains record of the quantity received, issued and balance stock
of the starting material, intermediate product, bulk product or
finished product at any time.
The inventory card shall contain the following data:
 material or product name and code number
 date of receipt and issuing or delivery
 quantity received or issued and the balance stock
 batch number of material or product
 storage location and
 status of material or product, whether under quarantine, released or rejected
 It is recommended to use different colors of inventory
card for each group of product like active material,
 excipient, packaging material, intermediate product,
bulk product or finished product.
The inventory card shall follow the first-in-first-out(FIFO) principle.
Deviation from this principle shall be for a short term and only when approved by an authorized manager.

b. Personnel
i. Training and Seminars
 All employees who are directly and indirectly engaged in the
manufacturing activities shall be trained in the particular operations that the employees perform in
accordance with the principles of Current Good Manufacturing Practice.
 Training shall be conducted by qualified individuals. Special attention shall be given to training of personnel
working in sterile and clean areas or with highly potent, toxic or sensitizing materials.
 Training in Current Good Manufacturing Practice shall be on a continuing basis and with adequate frequency
to assure that employees remain familiar with the Current Good Manufacturing
 Practice requirements relevant to their functions.
ii. Qualifications
 The production manager shall be a PRC registered qualified pharmacist or any other related profession.
He/she shall be adequately trained and shall possess good practical experience in the field of
pharmaceutical manufacture and managerial skill, which enable him/her to perform his/her function
effectively. The production manager shall have full authority and responsibility to manage production of drug
products.
 The quality control manager shall be a PRC registered qualified pharmacist or any other related profession.
He/she shall have adequate training and practical experiences that will enable him/her to perform his/her
function effectively. The quality assurance manager shall have full authority and responsibility in all quality
control processes such as establishment, verification and implementation of all quality control procedures.
He/she shall have the sole authority to approve starting materials, intermediates, bulk and finished products
that meet the specification or to reject those which do not conform to the relevant specification or which are
not manufactured in accordance with the approved procedures.
 The production manager and the quality assurance manager are jointly responsible to establish for the
quality, strength, purity and efficacy of the finished products
iii. Monitoring Systems
 Materials shall be stored in an orderly manner to prevent any risk of mix-up or contamination and to facilitate
inspection and maintenance. Materials shall be stored off the floor and sufficiently spaced.
 Storage operations shall be adequately segregated from other operations. Storage operations shall be
adequately segregated from other operations.
 All deliveries to storage areas, including returns, shall be properly documented. Each batch of starting and
packaging materials, intermediates, bulk products and finished products in storage areas shall have an
inventory system. Inventory system shall be periodically reconciled and if there is any discrepancy found it
shall be verified and justified when the quantity approved for use is different from the original receipt or
delivery. This shall be documented with a written explanation.

c. Components, Containers, and Closures

 Intermediates, bulk products and finished products shall be held pending quality control testing and disposition.
 Each container of intermediates, bulk products and finished products delivered to the storage area shall be checked for
proper identification and condition.
 If the identity or condition of any container of intermediates, bulk products and finished products is suspected, or does
not comply with the requirements of identity or condition, that container shall be retained in the quarantine for quality
control inspection and disposition

2. Give the different kinds of contamination. Discuss how each will affect the quality of the products produced.
 Particulates contaminant/microbial contamination
Particulates appear rough and uneven, degrading the appearance of the finished product. Particulates can also cause more
serious local defects by interfering with the bonding between the plated coating and base metal.

 Physical risk contamination

 Physical risks can get into product by contamination or poor procedure practices throughout the manufacturing of
products. Physical contaminants include dirt, hair, nail polish flakes, insects, broken glass, nails, staples, plastic fragments,
bones, or bits of packaging that can affect the quality of the product by destroying the active ingredients that may cause harm to
consumers.

 Chemical contaminants
The phrase 'chemical contamination' is used to indicate situations where chemicals are either present where they shouldn’t be,
or are at higher concentrations than they would naturally have occurred. Chemical contaminants can be found as organic and
inorganic molecules in mass produced products used day to day by almost everybody. These include plastics, resins,
pharmaceuticals, disinfectants, deodorants, detergents, petroleum products, road runoff, pesticides and biocides, along with the
results of land fill and incineration.
Some contaminants can increase bacteria growth and oxygen consumption within the production that can cause harm to the
products produced.
There are two types of chemical contaminants:
 Organic contaminants
These include oil and petrol spills from roads and concreted areas, hormones, pesticides, herbicides, and fungicides
originating from agricultural and horticultural industries that are situated close to waterways and or production area.
Organic contaminants are not only present as single molecules dissolved in water but can also be found as
suspended solids.
 Inorganic contaminants
Inorganic contaminants include nitrogen (N), phosphorus (P) and potassium (K). Increases in these simple chemicals
in waterways are nearly always as a result of land use activities like fertiliser runoff or direct discharges from industry.
Both the concentration of these chemicals and the means by which they enter a waterway vary greatly. Inorganic
contaminants also include metals and metal particles. These can be found in storm water runoff from urban
development and will accumulate in drainage systems or low lying areas of land. Many of these contaminant sources
eventually discharge into waterways with little prior treatment to remove chemicals.

3. Describe three (3) manual tasks required in the process of manufacturing products and justify why automation is not preferred to perform
them.
 Packing
Automation is not preferred because bulk products should be checked many times by the personnel to ensure the products’
correctness and are ready to be marketed to the public.
 Quality Control of products during Packaging
This is to ensure that every product and packaging is of good quality and would contain the correct amount of drug products per
packaging
 Folding of medicinal boxes
This is to ensure that the medicinal boxes used are of good quality, does not have any defects and would contain the correct
information required in the medicinal box.
 Activity No. 4

DOCUMENTATION

Objectives:

At the end of this activity, the student is able to:

1. Familiarize himself with the different documents/ control sheets / monographs used particularly in the Production and Quality Control
Areas.
2. Learn how to properly fill out different types of documentations.

Procedure:

A. Group
1. Attach different documents used in the following areas: ( PLEASE ASK TO PHOTOCOPY THESE)
a. Production Area
 b. Quality Control Area

c. Warehouse

2. Describe the importance of proper filing and endorsements of documentations as part of normal manufacturing activities. Be able to cite at
least 3 of these reasons.
The importance of proper filing and endorsements of documentations as part of normal manufacturing activities is to define the
specifications and procedures for all materials and methods of manufacture and control. Another is to ensure that all personnel concerned
with the manufacture knows what to do and when to do it or whether or not to release a batch of a drug for sale. It also help in providing
traceability of documented evidence, data needed for validation, review and statistical analysis, records and an audit trail that will permit
investigation.
3. List the different references/ books used for purposes of documentation and filling of monographs.

–The different references/ books used for purposes of documentation and filling of monographs are the following:

a. Latest United States Pharmacopeia/National Formulary

b. British Pharmacopeia Latest Edition
c. Remington’s Pharmaceutical Sciences
d. Merck Index
e. Drug Reference Manual
f. BFAD Regulations/Pharmacy Laws
g. Official Philippine National Drug Formulary
 Activity No. 5

MANUFACTURE OF PHARMACEUTICALS

Objectives:

At the end of this activity, the student is able to:

1. Observe the flow of manufacture of each of products in the actual production set-up.
2. Identify the different equipment used in the manufacture of pharmaceuticals.

Procedure:

1. Attach drawings or pictures of the typical equipment used in the manufacture of the different products produced by the manufacturing
company. PLEASE SEEK PERMISSION TO DO THIS BEFORE TAKING PICTURES.
The interns were not able to take pictures of the equipment used in the manufacturing of different products produced by the manufacturing
company due to confidential reasons as stated by the employees working in the manufacturing site. Pictures taken from the internet which
the interns were able to see at the site were attached as a substitute.

Figure 1 POWDER MIXER Figure 2 TABLET COMPRESSION MACHINE

Figure 3 DRY INK BATCH CODE Figure 3 PINHOLE DETECTOR MACHINE

 2. Choose 3 products currently made by the manufacturing company, and present a schematic diagram/chart to show the flow of their
manufacture.
The interns were only able to have a hands-on experience in two products made by the manufacturing company which are Sambong and
Lagundi tablets. Both products have the same flow chart of their manufacture:

COLLECTING DRYING

SEIVING BLENDING

COMPRESSION

FILM COATING BLISTER PACKING

SCREENING CODING PACKING

STRIP SEALING SHIPPER CARTOONING

QUARANTINE FG STORE DISTRIBUTION

3. Describe the cleaning processes done to equipment before initiating actual use of them in production. When do they conduct cleaning
validations for these?
Schedules and procedures (including assignment of responsibility) should be established for the preventative maintenance of
equipment.

Written procedures should be established for cleaning equipment and its subsequent release for use in the manufacture of
intermediates and APIs. Cleaning procedures should contain sufficient details to enable operators to clean each type of equipment in a
reproducible and effective manner. These procedures should include:

a) Assignment of responsibility for cleaning of equipment

b) Cleaning schedules, including, where appropriate, sanitizing schedules
c) A complete description of the methods and materials, including dilution of cleaning agents used to clean equipment
d) When appropriate, instructions for disassembling and reassembling each article of equipment to ensure proper cleaning
 e) Instructions for the removal or obliteration of previous batch identification
f) Instructions for the protection of clean equipment from contamination prior to use
g) Inspection of equipment for cleanliness immediately before use, if practical
h) Establishing the maximum time that may elapse between the completion of processing and equipment cleaning, when
appropriate

Equipment and utensils should be cleaned, stored, and, where appropriate, sanitized or sterilized to prevent contamination or
carry-over of a material that would alter the quality of the intermediate or API beyond the official or other established
specifications.
Where equipment is assigned to continuous production or campaign production of successive batches of the same intermediate
or API, equipment should be cleaned at appropriate intervals to prevent build-up and carry-over of contaminants (e.g.,
degradants or objectionable levels of microorganisms).
Nondedicated equipment should be cleaned between production of different materials to prevent cross-contamination.
Acceptance criteria for residues and the choice of cleaning procedures and cleaning agents should be defined and justified.
Equipment should be identified as to its contents and its cleanliness status by appropriate means.

4. What products are manufactured in the same production section and which are not? Justify.
Lagundi and Sambong tablets are both manufactured in the same production section while Herbal soaps are in different area due to one
reason which is to be organized so as not to encounter many mix-ups and back jobs resulting to waste of time and effort. For classification,
collocation and complexity of use, tablet and soap production should be in different sections. Tablets, mainly for internal use and soaps for external
use have different precaution and circumspection therefore; they are not in the same production section.
 Activity No. 6

IN-PROCESS QUALITY CONTROL

Objectives:

At the end of this activity, the student is able to:

1. Familiarize oneself with the different sampling and quality control tests done on different dosage forms.
2. Understand the proper disposition of materials after evaluation of results.

Procedure:

A. Group
1. Describe the importance of sampling of products as part of inspection protocols.
Sampling is important since it is required for different purposes, such as pre-qualification, acceptance of consignments, batch release
testing, in-process control, special controls, inspection for clearance, deterioration or adulteration and for obtaining a retention sample.

2. Describe the quality tests for 2 different dosage forms, currently being manufactured.
Tablets:

a. TABLET HARDNESS:
The test measures crushing strength property defined as the compressional force applied diametrically to a tablet which just fractures it.
Among a large number of measuring devices, the most favored ones are Monsanto tester, Pfizer tester, and Strong cobb hardness tester.
b. FRIABILITY TEST:
This test is additional to check crushing strength of tablet by this test one can check Capping &/or Lamination. USP limit is 0.5 to 1%.
Rotation: - 25 rpm or 100 rotations in 4 min. For this test twenty tablets are weighed and placed in the friabilator and then operated at 25
rpm for 4 minutes. The tablets are then dedusted and weighed. The difference in the two weights is used to calculate friability and the
value of friability is expressed in percentage.
c. Weight Variation:
According to the USP, weight variation test is run by weighting
20 tablets individually calculating the average weights and comparing the individual tablet weights to the average. The value of weight
variation test is expressed in percentage.
d. Content Uniformity Test:
This test ensures that every tablet contains the amount of drug substance intended with little variation among tablets within a batch.
This test is conducted by Randomly selecting 30 tablets. 10 of these assayed individually. The Tablet pass the test if 9 of the 10 tablets
must contain not less than 85% and not more than 115% of the labeled drug content and the 10th tablet may not contain less than 75%
and more than 125% of the labeled content.
If these conditions are not met, remaining 20 tablet assayed individually and none may fall outside of the 85 to 115% range.
e. Disintegration Test :
USP Disintegration <701> can be used to measure the time it takes for tablets or capsules to dissolve. There should be specifications if
tablets or capsules are uncoated, coated, delay-release, rapid-release, hard gel, soft gels or other forms. The disintegration testing uses a
cylinder with six tubes immersed in a liquid solution at 35 to 39 degrees Celsius. This cylinder is suspended from an arm that raises and
lowers it into liquid at a constant frequency rate. This test simulates digestion in the stomach or small intestine, and measures the time it
takes for the tablet or capsule to dissolve.
f. Dissolution test:
Tablet Dissolution is a standardized method for measuring the rate of drug release from a dosage form. The BP or USP dissolution
apparatus (Basket apparatus) consist of a cylindrical vessel with a hemispherical bottom, which may be covered, made of glass or other
inert, transparent material; a motor; a metallic drive shaft; and a cylindrical basket. The vessel is partially immersed in a suitable water bath
of any convenient size or heated by a suitable device such as a heating jacket. The water bath or heating device permits holding the
temperature inside the vessel at 37 ± 0.5 °C during the test and keeping the bath fluid in constant, smooth motion

3. How does quality control function differ from those of quality assurance?
QC is a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced. QC
aims to identify (and correct) defects in the finished product. Quality control, therefore, is a reactive process. The goal of QC is to identify
defects after a product is developed and before it's released. Quality control is concerned with the operational activities and techniques that
are used to fulfill the quality requirements. Quality control functions start once the project work has begun. Quality control is a reactive
approach and helps you find defects in deliverables. The objective of the quality control process is to make sure that the deliverables are
 defect free and acceptable as per the quality requirements. If the deliverable has a defect, you will take any suitable corrective action.
While, Quality assurance is a process based approach whose prime objective is to prevent defects in deliverables in the planning stage to
avoid rework, which costs a lot. Quality assurance is a proactive process and it emphasizes planning, documenting, and finalizing the
guidelines that will be necessary to assure the quality. This process starts at the very beginning of the project to understand the product’s
requirements and expectations.QA aims to prevent defects with a focus on the process used to make the product. It is a proactive quality
process. The goal of QA is to improve development and test processes so that defects do not arise when the product is being developed.

4. Attach drawings or pictures of instruments used in different in- process quality control tests. Be able to specify the dosage form being tested
as well as the parameter that is measured by each of these instruments. PLEASE SEEK PERMISSION TO TAKE PICTURES BEFORE DOING
THIS.
Instrument Dosage form tested Parameter tested

Tablet
Tablet Hardness

Tablet Hardness tester

Tablet Tablet Hardness

Monsanto tablet hardness tester

Tablet Tablet Hardness

Portable Tablet Hardness tester

Tablet Tablet Disintegration time

Tablet Disintegration tester

 Tablet Tablet’s Friability

Tablet Friability tester

Tablet Moisture content

Moisture content analyzer

 Activity No. 7

SAMPLING AND INSPECTION

Objectives:

At the end of this activity, the student is able to:

1. Familiarize oneself with the different sampling and inspection plans.

2. Understand how defects can be determined, traced, and avoided in the manufacture of pharmaceuticals.

Procedure:

A. Group
1. Define the following terminologies:

a. Sample – a small part or quantity intended to show what the whole is like
b. Sampling plan - is a detailed outline of which measurements will be taken at what times, on which material, in what manner, and by
whom. It should be designed in such a way that the resulting data will contain a representative sample of the parameters of interest
and allow for all questions, as stated in the goals, to be answered.
c. Inspection - the act of looking at something closely in order to learn more about it, to find problems, etc.
d. 100% Inspection - A process which requires the inspection of each individual unit or component received from a supplier to determine
specification and quality compliance.
e. Defects - a physical problem that causes something to be less valuable, effective, healthy, etc.
f. Disposition Codes or colors - a two-digit code indicating the means of product removal from the report entity.

2. IF POSSIBLE, attach a sample control chart to evaluate a described parameter of one of the products being manufactured.

3. Justify why random sampling is important in inspection processes.

Random sampling eliminates bias by giving all individuals an equal chance to be chosen. Randomly selecting the members of a
sample is important because it helps prevent bias in the results. Random selection allows impersonal choice to choose the sample,
rather than the individual performing to select their own. If a sampler does not use random selection, the sample will favor selection of
certain groups, possibly without the sampler even realizing it.