PRACTICE SCHOOL ON RESEARCH AND DEVELOPMENT

KEY HIGHLIGHTS-
1-JOB PROFILES IN RESEARCH AND DEVELOPMENT
I-PROJECTS
II-MOLECULES
2-INNOVATION TO DRIVE INNOVATIVE GENERICS

3-CADD-Computer Aided Drug Design

4-CULTURE OF INNOVATION IN NEW CHEMICAL ENTITIES

5-NEW DRUG APPLICATION

6-NEW PRODUCT SELECTION AND INTEGRATED PRODUCT DEVELOPMENT

7-ANALYSIS OF RAW MATERIAL

I-Packing Materials
ii-monitoring in process quality control and quality assurance

8-DESIGNING DEVELOPING AND VALIDATING NEW ANALYTICAL METHODS

9-PROCESS VALIDATION

10-PREPARATION OF SOPS COMPLIANCE WITH GMP ,ISO,HACCP,FDA

 JOB PROFILES IN RESEARCH AND DEVELOPMENT
[PROJECTS AND MOLECULES]

There are many disciplines, the majority of which are biological sciences related, that
work in collaboration through the R&D process in a Pharma industry setting.
Common fields for research positions that are involved in the in vitro and in vivo
testing of drug candidates include, pharmacology, immunology, molecular biology,
virology, microbiology, cell biology and neuroscience. Compounds are also tested for
toxicity by researchers working in the drug metabolism and pharmacokinetics
(DMPK) teams.

Most entry level research jobs, after completing a PhD. or postgraduate course, have
a title of ‘Scientist’ or ‘Senior Scientist.’ Promotional paths include moving on to a
Lab Head or Team Lead role, then the Head of a particular department or research
area and subsequently, Director.

Typical pharmaceutical scientists spend most of their time in a laboratory

discovering and learning how different compounds interact with disease-causing
cells and organisms. In addition, they investigate how these compounds interact
with the human body to ultimately determine if they can become new drugs.

Developing new drugs takes a very long time and costs a great deal of money. There
are three stages to this process:

Development: Administering the new drug to animals and humans to make

sure it is safe and effective

Discovery: Identifying new compounds that help treat disease

Manufacturing:Producing the new drug in large quantities for distribution

Creating new medicines requires a large team of scientists with training in many
different scientific disciplines including various areas of chemistry, biology,
engineering, informatics and medicine During the discovery phase, pharmaceutical
scientists may examine thousands of molecular compounds before they find one
that effectively fights disease without harming the patient. Alternatively, hundreds of
molecular pathways are evaluated to determine if a protein can alter the signaling in
a beneficial way. If a pharmaceutical scientist identifies a promising new compound
or target today, it may take up to 20 years before the medicine is available in your
drug store.

ACADEMIC REQUIRMENTS-
To become a pharmaceutical scientist, you must have a strong interest in
mathematics, biology, chemistry and the scientific process. You may want to decide
early on which aspect of the drug development cycle you want to focus on –
discovery, development or manufacturing. In college, you can major in the
pharmaceutical sciences, pharmacy, biology, chemistry, medicine, engineering or a
related field.

Good communications skills are important, because you’ll be working as part of a

scientific team made up of people with diverse backgrounds. You’ll need to be able
to stay motivated and keep your team energized throughout the long development
process. You also must be able to handle failure and disappointment: Most
promising new drugs are rejected before they ever reach the market, because they
are dangerous, don’t work consistently or have unacceptable side effects.

Many pharmaceutical scientists begin working in the field after college and then go
on to complete advanced degrees in more specialized subjects. Pharmaceutical
companies often pay for talented workers to complete graduate and post-graduate
degrees, such as Master of Science (M.S.), Master of Public Health (MPH), Doctor of
Medicine (M.D.), Doctor of Pharmacy (Pharm.D.) or Doctor of Philosophy (Ph.D.), to
help them qualify for advancement.

CAREER IN MOLECULAR MODELLING

The average price of developing new drug molecules and therefore the time that is
taken to publicize them is quite high. The time factor to some extent is being
reduced by utilizing modern techniques but the price issue remains a matter of
concern.

The career in molecular modelling includes

1-scientist

2-professorship

3-project assistant
4-research associate

5 bio informatics in health sector

6-research technician

7-computational biophysicists

SALARY DETAILS -
As we have already checked salaries in this field range from Rs 3 lakh per year for
research associate to Rs 10 lakh per year for managerial post. With increasing
responsibility ,compensation also grows significantly .They also can receives
bonuses throughout development of a new drug

CULTURE OF INNOVATION TO DRIVE INNOVATIVE

GENERICS
Four steps to building an innovation culture in pharma
The quest for innovation is a major driving force in pharma. From the discovery of
therapeutic biologicals in the 1920s, such as Salvarsan and insulin, to the
blockbuster drugs birthed in the 1990s, such as Lipitor and Humira, pharma has
always been on a quest for novel, groundbreaking drug development.

However, advancements in technology are constantly transforming how industries

and thought leaders operate. Even though the desire for innovation is still at the core
of pharma, the industry is still struggling with slower and less efficient traditional
R&D models – and is consequently lagging behind in optimizing the benefits of new
models of innovation. In order to remain competitive, pharmaceutical companies
must learn to foster a culture of innovation at every level of their organization and at
every stage of drug development

1-BE HONEST ABOUT FAILURE

Most researchers want to learn from failure, but only a few are publicly transparent
about failure. When a clinical trial fails to achieve the intended results, newer studies
can benefit from the lessons learned in that failure. However, the researchers
lessons that they learned in the process.

2-BUILD DATA ANALYSIS AS A CORE COMPETENCY

In the past, the core competencies of pharmaceutical companies were research and
marketing. Recently, data analysis has become a forerunner on the list of core
competencies.

In order to be increasingly innovative in the discovery of novel drugs, pharma

companies must be empowered to elevate their data analysis capacities. They need
to exercise control over their own data analytics and not merely rely on an external
organisation to help them leverage their own data. That’s why we don’t simply sell a
product or service – we sell an ecosystem that empowers in-house analytics teams
to work faster and smarter.

3-ENCOURAGE CROSS FUNCTIONAL COLLABORATION

Data silos and lack of open data are big challenges in pharma. Pharma companies
should incentivise researchers to share insights with one another and to collaborate
on projects.

They need to engage more in new open innovation models that encourage sharing of
data without the risk of losing intellectual property. Examples of open innovation
models are open sourcing, crowdsourcing, public-private partnerships (PPPs),
collaborations with academic centers and outsourcing to virtual R&Ds.

4-AUTOMATE LOWER LEVEL COGNITIVE TASKS

To focus on creativity and innovation, researchers in pharma need to spend less time
performing lower-level cognitive tasks, such as administrative work and collecting,
cleaning, and organising data. Performing these tasks limits thinking outside the
box. Researchers need a larger brain bandwidth to achieve ‘Aha!’ moments.

Research by McKinsey and Company shows that about 45% of tasks people are paid
for can be automated using technology. Examples of automation technologies within
pharma and healthcare include IBM’s Watson and Innoplexus’ iPlexus platform.

COMPUTER AIDED DRUG DESIGN

CADD is a modern computational technique used in the drug discovery process to

identify and develop a potential lead [10, 14, 15]. Computer-aided drug design
includes computational chemistry, molecular modeling, molecular design and
rational drug design. CADD is being used to optimize identified leads.
Computer-aided drug design (CADD) has been credited to the modern patterns in
compound characterization in drug discovery following its inception in 1981 [43]. It
represents an advancement when compared to HTS as it requires minimal
compound design or prior knowledge, but can yield multiple hit compounds among
which promising candidates have been elected. The typical role of CADD in drug
discovery is to screen out large compound libraries into smaller clusters of predicted
active compounds (Figure 5.1), enabling optimization of lead compounds by
improving the biological properties (like affinity and ADMET) and building
chemotypes from a nucleating site by combining fragments with optimized function.

Clustering has been applied as a means to select representatives from screening

libraries [44]. Screening hits include molecules that specifically bind to the target in
addition to a greater number of nonspecific compounds requiring a triaging process
to filter these out . Thus, such a large library that contains a number of possible hits
is further downsized and clustered into series.

Computational chemistry algorithms have been developed to group hits based on

structural similarity, which is necessary to ensure that compounds are adequately
sorted over a broad spectrum of chemical classes. Thus, selection of hits would be
based on chemical cluster, potency, and factors such as ligand efficiency (which
gives an idea of how well a compound binds for its size).

The increasing application of diverse computerized methods in drug discovery has

enabled a better handling of data associated with a large number of compounds
screened against the target molecules or proteins for leads. Computational tools
help to define and elaborate the strength of interaction between ligands and targets,
and have been instrumental in the identification of lead molecules from databases.
Nevertheless, the lack of specificity leads to low hit rate for HTS, which could limit its
applicability and efficiency in screening large compound libraries. CADD is a more
targeted approach to the generation of “hits” when compared with traditional HTS. It
enables the elucidation of the molecular basis of therapeutic activity and possible
derivatives, and those variables that could be applied or improved for generating an
optimal drug compound, thus leading to prioritization of the actives without requiring
extensive development and validation prior to use, as in the case of assay HTS. The
CADD approach has played a vital role in the search and optimization of potential
lead compounds with a considerable gain in time and cost. It has been applied
during various stages in drug discovery: target identification, validation, molecular
design, and interactions of drug candidates with targets of interest [45].

CADD can be structure or ligand based. Structure-based CADD seeks the knowledge
of the target protein structure in the determination of interaction levels of all
compounds being examined. Ligand-based CADD relies on the chemical similarity
criteria, and the predictive, quantitative structure–activity relationship (QSAR)
models that it creates from the molecules to determine the known active and
inactives [46]. QSAR modeling enables understanding of the influence of structural
factors on biological activity, using the models and the understanding to construct
compounds with improved and optimal biological profiles. Other methods for
quantitative description of structural change are comparative molecular field
analysis and GRID.

Structure-based CADD is a preferred choice for soluble proteins that could be

crystallized, while ligand-based CADD is better suited for compounds with high
binding affinity to the target, devoid of off-target effects, and that could be designed
with minimal free energy, favorable drug metabolism, and pharmacokinetic/ADMET
properties [47]. In general, CADD is better suited for occasions where sparse
structural information is available. This is usually the case for membrane protein
targets.

CADD helps scientists in minimizing the synthetic and biological testing efforts by
focussing only on the most promising compounds. Besides explaining the molecular
basis of therapeutic activity, it also predicts possible derivatives that would improve
activity. CADDD entails (Kapetanovic, 2008):

Drug discovery and development processes being streamlined by the use of

computing power.

Identification and optimization of new drugs using leverage of chemical and

biological information about targets and/or ligands.

In silico designing of filters for the elimination of undesirable compounds with

properties like poor activity and/or poor absorption, distribution, metabolism,
excretion and toxicity, ADMET which facilitate selection of the most promising
candidates.

ADVANTAGES OF CADD

The main advantages of drug discovery through CADD are:

I -For experimental testing, smaller set of compounds are selected from large
compound libraries.

II-Drug metabolism and pharmacokinetics (DMPK) properties like absorption,

distribution, metabolism, excretion and the potential for toxicity (ADMET) are
increased by optimization of lead compounds.
III-Designing of novel compounds can be achieved either by “growing” starting
molecules one functional group at a time or by piecing together fragments into novel
chemotypes (Veselovsky and Ivanov, 2003).

IV-Traditional experimentation which requires animal and human models can be

replaced by CADD, saving both time and cost (Mallipeddi et al., 2014).

V-Reduces the chances of drug resistance and thus would lead to production of lead
compounds which would target the causative factor.

VI-CADD also leads to the construction of high quality datasets and libraries that can
be optimized for high molecular diversity or similarity (Ou-Yang et al., 2012).

TYPES OF CADD-
The choice of CADD approaches to be employed is determined by the availability of
the experimentally determined 3D structures of target proteins. Structure-based
CADD uses our knowledge of the target protein structure to calculate interaction
energies, whereas in ligand-based CADD, chemical similarity searches or
construction of predictive, quantitative structure-activity relationship (QSAR) models
exploits our knowledge of known active and inactive molecules.(Kalyaanamoorthy
and Chen, 2011). Structure based CADD combines information from several fields,
for example, X-ray crystallography and/or NMR, synthetic organic chemistry,
molecular modelling, QSAR, and biological evaluation (Marrone et al., 1997). Through
structure based CADD, we aim to design compounds with strong binding affinity with
the target, thereby exhibiting properties like reduced free energy, improved
DMPK/ADMET properties and target specification i.e., reduced off-target (Jorgensen
et al., 2010). Virtual high-throughput screening (vHTS) also known as screening of
virtual compound libraries is one of the most common applications of CADD
Kalyaanamoorthy and Chen, 2011). Fig. 6 represents an overview of CADD drug
designing/design pipeline.

STRUCTURE BASED DRUG DISCOVERY

This method exploits knowledge of the three-dimensional structure of a receptor

complexed with a lead molecule for optimization of the bound ligand or a series of
congeneric molecules. It requires the understanding of receptor–ligand interactions.
The structural information can be obtained either from X-ray crystallography, NMR,
or from homology modelling. A medicinal chemist can use a model with a given
structure for computing the activity of a molecule (Lewis, 2005). Some of these
approaches provide accurate binding modes, while cater to fast searching of large
databases. Some approaches of structure-based drug designing are explained
below.
Structure-based virtual high-throughput screening -
Structure-based virtual high-throughput screening (SB-vHTS) is an in-silico method
which helps identify putative hits out of hundreds of thousands of compounds to the
targets of known structure. It is usually based on molecular docking. In molecular
docking, a small molecule is fitted into the active site of protein model and here,
comparison of the 3D structure of small molecule with the putative binding pocket is
carried out. In the traditional HTS, the general ability of a ligand to bind, inhibit or
allosterically alter the proteins function is asserted experimentally, whereas in SB-
vHTS selects the ligands that are predicted to bind to a specific binding site. To
ensure the feasibility of screening of large compound libraries within a finite time,
limited conformational sampling of proteins and ligands is used by SB-vHTS along
with a simplified approximation of binding energy that can be computed rapidly
(Becker et al., 2006).

STRUCTURE BASED VIRTUAL SCREENING-

This is a computational approach for identifying potential drug candidates (hits) that
are capable of binding to a drug target (protein receptors, enzymes). This method
involves quick searching of large libraries of chemical followed by docking of the hit
into a protein target and finally application of a scoring function for estimating the
probability of binding affinity of drug candidate with the protein target (Cheng et al.,
2012). The most important advantage of this screening is that it enhances the hit
rate by considerably decreasing the number of compounds that are estimated
experimentally for their activity and hence improves the success rate of the in vitro
experiments. This method has been applied extensively in pharmaceutical
companies and academic groups for early-stage drug discovery.

FRAGMENT BASED LEAD DISCOVERY-

This approach is based upon structure-activity relationships (SAR), obtained from

NMR for identifying and optimizing the lead (Bienstock, 2011). High purity, weak
potency but effective binding, good aqueous solubility, (molecular weight<300,
ClogP<3, number of rotatable bonds, number of hydrogen bond donors and
acceptors each should be <3) are the criteria for selecting the chemical fragments
(Congreve et al., 2003). Later, these fragments are either expanded or combined for
producing a lead with a higher affinity.

IN SILICO STRUCTURE BASED LEAD OPTIMIZATION-

After the desired hits are identified through virtual screening, this method speeds up
the search for optimized lead by delineating the prediction about its pharmacological
properties, thereby reducing the in vitro and in vivo experimental time.

ADMET MODELLING-
This method, a common name for which is physiologically-based pharmacokinetic
modelling is used in drug design and development, and in assessing of toxicity threat
evaluation and specifically predicts absorption, distribution, metabolism, excretion
and toxicology (ADMET) of drugs/compounds in humans. The ADMET parameters
are based on the kinetics of the drug exposure to tissues and how the body will react
to them, influencing the performance and pharmacological activity of the compound.
Therefore, this method provides a key insight into the behaviour of a pharmaceutical
compound within an organism. This approach aids in the selection of compounds
during the very early phases of drug thereby playing a crucial role in drug discovery
and development. This technique is cost- and time effective owing to a reduction in
attrition of drugs during the pre-clinical / clinical phase trials at a later stage.

LIGAND BASED DRUG DESIGINING-

The existing knowledge of active compounds against the target is used to predict
new chemical entities that present similar behaviour in Ligand-based methods
(Martin et al., 2002). Given a single known active molecule, a pharmacophore model
can be derived from a library of molecules to define the minimum necessary
structural characteristics a molecule must possess in order to bind to the target of
interest. A fingerprint-based similarity search is usually used to compare the active
molecule to the library as here, the molecules are represented as bit strings which
represent the presence or absence of predefined structural descriptors (Mishra and
Siva-Prasad, 2011). In comparison, targeting structural information to determine
whether a new compound is likely to bind and interact with a receptor is the method
that structure-based methods rely on. No prior knowledge of active ligands is
required in this method, which is a significant advantage (Kolb et al., 2009). It is
possible to design new ligands that can elicit a therapeutic effect from 3D
structures. Therefore, the development of new drugs through the discovery and
optimization of the initial lead compound are greatly impacted by structure-based
approaches.

LIGAND BASED VIRTUAL SCRENNING

Ligand-based virtual screening is based on the “similarity principle” according to

which similar molecules tend to exhibit similar biological properties. Scaffold
hopping i.e., identification of iso-functional molecular structures with significantly
different molecular backbones is the usual objective when using LBVS. “Scaffold
hopping” is also known as “leapfrogging”, “scaffold searching” and “leap hopping”
(Kalliokoki, 2010). These methods are usually helpful in drug repurposing, wherein
new targets and diseases are pursued for existing drug molecules.

MOLECULAR DESCRIPTORS-
This is one of the simplest approaches in which the reference molecule/set of
molecules are compared with a large library of compounds at a very low cost on the
basis of physicochemical properties descriptors, such as molecular weight, volume,
geometry, surface areas, atom types, dipole moment, polarizability, molar refractivity,
octanol-water partition coefficient (log P), planar structures, electronegativity, or
solvation properties that are obtained from experimental measurements or
theoretical models. Molecules are represented by symbols for effective execution of
the task (Prada-Graciaa et al., 2016)

QUANTITATIVE ACTIVITY STRUCTURE RELATIONSHIP MODELS -

The mathematical relation between structural attributes and target response for a
set of chemicals are explained by Quantitative Structure-Activity Relationship
models. Structural and/or property descriptors of compounds can also be correlated
with their biological activities using QSAR (Bernard et al., 2005). Through QSAR
models we can correlate various features like rate constants, binding sites affinities
of ligands, inhibition constants and other biological activities, either with certain
structural features (Free Wilson analysis) or with atomic, molecular or group
properties, such as lipophilicity, electronic, steric and polarizability, among
congeneric series of compounds. (Kubinyi, 1995). Hence, the success of QSAR is
dependent on the choice of descriptors and the ability to generate the appropriate
mathematical relationship besides the quality of initial set of active/inactive
compounds.

PHARMACOPHORE MODELLING-

More significant information can be drawn by employing various conformations of a

range of ligands than just a single ligand structure. A pharmacophore model of the
receptor site can be generated with a sufficiently broad range of ligands.
Pharmacophore modelling of smaller, non-peptide molecules that might have
improved stability and bioavailability over their peptide counterparts has resulted in
successful outcomes so far (Nielsen et al., 1999)

SOFTWARE AVAILABALE FOR COMPUTER AIDED DRUG DESIGN-

Commercially available CADD software packages include Discovery Studio (55),

OpenEye (56), Schrödinger (57) and MOE (58). These programs, which can often be
obtained at a discount for academic users, cover most of the capabilities required
for CADD including both SBDD and LBDD methods.

CADD methods are mathematical tools to manipulate and quantify the properties of
potential drug candidates as implemented in a number of programs. These include a
range of publicly and commercially available software packages; the subset
described below represents examples of fundamental tools for CADD with emphasis
on those commonly used in our laboratory.

Commonly used MD simulation codes include CHARMM (27), AMBER (28), NAMD,
(29) GROMACS (30) and OpenMM (31). These programs run on a variety of
computer architectures including running in parallel on multicore central processing
units (CPU) and, more recently, optimized for graphics processing units (GPU), such
as those commonly used in video games.

For SBDD, the 3D structure of the protein, RNA or other macromolecule may be
obtained from the Protein Data Bank (PDB) (32) if it was solved by X-ray
crystallography or nuclear magnetic resonance (NMR) experiments. Alternatively, a
3D structure may be constructed using homology modeling methods with a program
such as MODELLER (33) or an on-line web server such as SWISS-MODEL (34).

In order to perform MD simulations, homology modeling, database screening or

other CADD techniques empirical force fields for the molecules of interest are
needed. These force fields are used by the respective programs to estimate the
energy and forces associated with, for example, a drug-protein complex. Force fields
such as those from the CHARMM (35–38) or AMBER (39, 40) families are used to
describe the internal and external energetic properties of a molecular system during
an energy minimization or a MD simulation. When parameters are missing in the
existing force field, which is common for small drug-like molecules, automated
parameter generation programs such as the CGenFF program (41, 42) or
Antechamber (43) can be used to complete the force field. It is important to note
that when using a force field the parameters for different parts of the system (e.g.
the protein and the ligand) need to be compatible, such that CGenFF should be used
with CHARMM or Antechamber with AMBER. In addition, when parameters are
estimated it is suggested that the user check the parameters with respect to their
accuracy in treating the energy as a function of conformation, as described for
CGenFF (37, 44, 45). To facilitate this process when generating parameters using the
CGenFF program (see https://cgenff.paramchem.org), penalties are assigned to
parameters estimated based on analogy, guiding the user with respect to
parameters that require checking.

NEW CHEMICAL ENTITES-

New chemical entities (NCEs, also known as new molecular entities or NMEs) are
compounds that emerge from the process of drug discovery. ... Together, these
processes are known in preclinical and clinical development as chemistry,
manufacturing, and control (CMC).
An NCE is a molecule developed by the innovator company in the early drug
discovery stage, which after undergoing clinical trials could translate into a drug that
could be a treatment for some disease. Synthesis of an NCE is the first step in the
process of drug development. Once the synthesis of the NCE has been completed,
companies have two options before them. They can either go for clinical trials on
their own or license the NCE to another company. In the latter option, companies can
avoid the expensive and lengthy process of clinical trials, as the licensee company
would be conducting further clinical trials and subsequently launching the drug.
Companies adopting this model of business would be able to generate high margins
as they get a huge one-time payment for the NCE as well as entering into a revenue
sharing agreement with the licensee company.

NEW DRUG APPLICATION TO CREATE NEW REVENUE STREAMS

For decades, tThe goals of the NDA are to provide enough information to permit FDA
reviewer to reach the following key decisions:

he regulation and control of new drugs in the United States has been based on the
New Drug Application (NDA). Since 1938, every new drug has been the subject of an
approved NDA before U.S. commercialization. The NDA application is the vehicle
through which drug sponsors formally propose that the FDA approve a new
pharmaceutical for sale and marketing in the U.S. The data gathered during the
animal studies and human clinical trials of an Investigational New Drug (IND)
become part of the NDA.

The goals of the NDA are to provide enough information to permit FDA reviewer to
reach the following key decisions:

Whether the drug is safe and effective in its proposed use(s), and whether the
benefits of the drug outweigh the risks.

Whether the drug's proposed labeling (package insert) is appropriate, and what it
should contain.

Whether the methods used in manufacturing the drug and the controls used to
maintain the drug's quality are adequate to preserve the drug's identity, strength,
quality, and purity.

The documentation required in an NDA is supposed to tell the drug's whole story,
including what happened during the clinical tests, what the ingredients of the drug
are, the results of the animal studies, how the drug behaves in the body, and how it is
manufactured, processed and packaged. The following resources provide
summaries on NDA content, format, and classification, plus the NDA review process:

INTEGRATED PRODUCT DEVELOPMENT-

An integrated development plan is a key step which covers pharmaceutical

manufacturing and its control, non-clinical and clinical aspects, the Target Product
Profile (TPP) and marketing and commercial factors. Integrated Product
Development Plan defines the goals and important claims of medicinal product.

ANALYSIS OF RAW MATEIALS-

Raw materials analysis ensures your drug development process begins with high-
quality substances that minimize impact on final product quality. The outputs are
only as good as the inputs. ... Contaminants and impurities present in the inputs can
negatively impact final product quality, performance, and safety.

The outputs are only as good as the inputs. Optimizing manufacturing processes
won’t get you very far if you don’t first consider the quality of the raw materials.
Contaminants and impurities present in the inputs can negatively impact final
product quality, performance, and safety. Determining the level of impurities that
begins to compromise final products will help you to maintain quality manufacturing
processes, avoid costly recalls, and even allow you to optimize supply chain volatility
and process costs.

Gateway Analytical provides proactive and reactive raw materials analysis. This
service allows our customers to have peace of mind knowing their products will
continue to meet the most stringent quality standards, or to quickly determine if
starting raw materials are the possible source for end product foreign particulate
matter. Our experts utilize an all-of-the-above approach that may include microscopy,
FTIR, Raman, and/or SEM-EDS depending on a project’s unique needs.

ANALYSIS OF PACKING MATERIALS

SOP FOR ANALYSIS OF PACKING MATERIALS
1-PURPOSE

To provide the procedure for the analysis of packaging materials.

2-SCOPE

Covers all the packing materials used in the factory.

3-REFERENCE-

IP & In House.

4-RESPONSIBILITY

Q.C CHEMIST

5-ACCOUNTABILITY

Quality control manager

6.0-PROCEDURE

6.1-OPERATION

6.1.1 Sample packing materials as per sampling of Packaging Materials

6.2-ANALYSIS
Check the following for various packaging components:

6.2.1- CARTONS
6.2.1.1Design (As per approved art work)

6.2.1.2 Check the entire supply

6.2.1.3-Text [as per approved art work]

6.2.1.4-color

6.2.1.5-improper pasting

6.2.1.6-cartooning

6.2.1.7-dirty appearance and any other abnormality

6.2.1.9-packaging code number

6.2.1.10-printing

6.2.1.11-holding of strips

6.2.1.12-grammage
PROCEDURE-
Cut and perfect square piece of 10cm*10 cm or 5 cm *5 cm or less, as per the size
of packaging material and weigh. Calculate Grams per sq.meter as per the formula

Wt in mg *100*100

GSM=---------------------------------------------------------------

Width in cm x length in cm *1000

MONITORING OF Q.C AND Q.A ACTIVITIES-