Current good manufacturing practices or CGMP, is part of a quality system covering the manufacture and

tessting of active pharmaceutical ingredients diagnostics, foods, pharmaceutical products and medical
devices, Cgmps are guidelines that outline the aspect of production and testing that can impact the quality
of a product.
GOOD LABORATORY PRACTICE
Good Laboratory Practice or GLP embodies a set of principles that provides a framework within which
laboratory studies are planned, performed, monitored recorded, reported and archived. These studies are
undertaken to generate data by which the hazards and risks to users, consumers and third parties including
the environment can be assessed for pharmaceuticals, agrochemicals, cosmetics, food additives, feed
additives and contaminers novol food, bio sides and detergents. GLP helps assure regulatory authorities
that the data submitted are a true reflection of the results obtained during the study and can be therefore
be relied upon when making risk or safety assessments.
There certain rules on how to record raw data,
The first one is using permanent ink, never to use a pencil
The second one is to Sign and date every entry to make sure that everyone knows who is responsible
The third one is to keep records in real time so there is no catching up later

Next, correct mistakes with a single strike out at the reason for adr sign and date this can so who is
responsible
Lastly, there are no rewrites, original are need, this will reduce transcription errors

SOP DEFINATION
The SOP is defined as detailed written instructions to achieve uniformity of the performance of a specific
function. The emphasis here is on function. The entire process will be covered in the work order. The sop
only covers a specific function of the entire process.

SOP FORMAT
Things that have to be included in every sop;
The first one is the company name and pagination. The company name and pagination such as page 3 of 7
must appear on every page of the document.
The next one is the title. The title should be descriptive because the procedure describes how to do
something the title should use directive language to declare what is being done to what. And sop titled
water for injections still is not descriptive of the procedures content a more appropriate title would be.
Operation for water for injection stiil.

Next is the identification and control procedures must be uniquely identified. This identification supports
accountability and traceability of the document throughout the facility and overtime as it changes. The
accountability and traceability of procedures are based on assigning them identification numbers or codes
and control numbers or codes such as revision or addition numbers. Next is the purpose, the purpose or
objective of a procedure should restate and expand a well written title, expand or quality the directive
language used in the title.
Next is the scope, the scope should provide limits to the use of the procedures, are there certain samples
that are appropriate to test by this method. Do this methods apply only to certain equipments or to certain
departments, is there a limit to the capacity volume or to through put of the procedure. State to what areas
this procedures does and does not apply.
Next is the responsibility
Who is responsible for performing the work described?
Who is responsible for reporting the work?
Are there special training or certification requirement?
Next is the procedure
Describe the procedure in a step by step chronological manner

Use active verbs in direct statements such as weigh 5grams of sodium hydroxide or at 500ml of purified
water
Lastly is the Calculation data handling and documentary requirements
Describe how the raw data are managed and reported

Work order
The work order provides a state of control over your operational steps. It should provide a record of who
did what and when. What materials were used and where they came from. A person looking at this
completed document should be able to reconstruct all aspects of what went on during the production
round, your job is to produce a document that when filled out will make this possible.
Executive summary
Executive summaries are much like other summaries in the other main goal is to provide a condensed
version of a longer report content, the key difference however is that executive summary are written to
someone who most likely does not have the time to read the original. An executive summary seeks to let
the reader in on what the real significance of the report is. What is the reader expected to respond to? The
reader is the decision maker who will have the responsibility of deciding on some issues related to the
report. The executive summary must be written with this in mind. The executive summary is usually no
longer that 10% of the original document. It can be anywhere from 1 to 10 pages long depending on the
reports length. There are self contained stand alone documents. your assignment I that each of the six
laboratories be complete. Each student will draft an executive summary where in each summary you will
describe the nature of the ladder. Then briefly outline work performed and Describe deviations if any
from expected results. Discuss how the success of this project and overall contract is impacted. Then
close with a summary of how this results fit in, with the overall scope of the content and then what is
coming up, what is the next experiment?

Host genotype
Carries a DNA fragment containg the expression of the system is under and is induced by the addition
of a non metabolic reducer, by altering concentration, can be obtained, there are also induction control in
the system that controls.
Once such control is the
This control is useful in monitoring target protein through purification and cleavage steps.

Plasmd vector
Have three very useful features,
The first one is used for affinity chromatography when purifying the protein
The second one is used in selection
The third one is used in screening

Cryogenic storage
It is not the only method to preserve cultures as one could also use agar slants or stabs, but the are only
useful for a period up to one year and they usual have to be kept at 4 degrees Celsius. Another method
will be lyophilized cultures which is one of the preferred method useful with bacteria that can not be used
with animal cells. It can be stored in excess for a least 15 years. Cultures could also be frozen strord non
cryogenically. The result for this kind of storage is highly variable, there also older methods or very
specific methods such as immersion under mineral oil where cultures can be kept up to one year. Cultures
can also be dried on sterile paper or in soil and can be stored for several years.

Cryopreservation; questions to consider

What should culture be grown on before freezing? The answer to this rich media
What should the growth state be when harvested? In early stationary phase
What cryoprotectant should used and how much? There are suitable cryoprotectants.

What type of container (cryovial) should be used? A container that can withstand cryopreserving
temperatures such as minus 100 degrees Celsius and that are leak proof
Must the culture be frozen slowly or rapidly? It should be frozen slowly at a rate of 1 degrees Celsius sper
minute when you throw you culture, you should do so in 1 to 2 minutes at 30 degrees Celsius.

Positive features concerning cryogenic storage

With storage below minus 1 degrees Celsius and a suitable cryoprotectant, essentially no microorganism
have been found to be less than 50% viable even after times in excess of 15 years.
Retention of plasmid is in unchanged form
Preparation of samples for freezing is quite simple and minimal labour is usually needed for the complete
process
Viability estimates can be made without preparing new cultures

Negative features concerning cryopreservation

Special refrigeration is required either liquid nitrogen storage or mechanical freezers.
Mechanical freezers are expenses and prone to breakdowns and often noisy
in the case of liquid nitrogen refrigerators initial cost can be significant if large units are purchased while
liquid nitrogen refrigerators are almost free of maintenance continuing cost of liquid nitrogen can be a
real concern as availability
in the case of liquid nitrogen, immersion storage is unwise yet equipment to maintain a constant level of
refrigeration adds to the cost of the operation

Useful info for laboratory experiment 1

Ecoli wet mass is approximately 1.4 picograms, this includes 75% liquid. Wet mass refers o the pellet of
Ecoli.
Next Ecoli dry mass is approximately 0.25 to 1 picogram

OD of 1 is approximately 1 mgr|ml of wet cells and again this is the pellet

The last X- gal plates Contains X-gal IPTG as the inducer and LB