2 -PHARMACEUTICAL MANUFACTURING - DEPARTMENTS

PHARMACEUTICAL MANUFACTURING production, packaging, and then this. The

DEPARTMENTS transportation will be taken care of the
shipping section.
DIFFERENT DEPARTMENTS
⚫ Production TOTAL QUALITY CONTROL DEPARTMENT
⚫ Total Quality Control Quality control and Quality Assurance Analyst
⚫ Engineering is necessary.
⚫ Storage Sections
⚫ Purchasing ⚫ Quality Control
⚫ Sales checks the quality of all the batches.
⚫ Research and Development ⚫ Quality Assurance
⚫ Miscellaneous They take care of the safety and quality of the
products. his department takes care of that,
PRODUCTION DEPARTMENT that is their main responsibility. To make sure
Sections that the product is safe and effective.
⚫ Procurement
or the purchasing area or the section in the ENGINEERING DEPARTMENT
production department where in the Tasks
procurement of the materials, ingredients, ⚫ Location and installation of equipment
chemicals and the equipment needed for to make sure that the location of the
the production of a specific pharmaceutical equipment is safe, and of course, it is free
product will be taken care of. from excessive heat and excessive
⚫ Storage coldness, basta any excessive temperature.
will take care of the purchased or the Kailangan yung location is maayos. Free
procured materials needed in the from dusty area, yung hindi masyadong
production. They have to make sure that madumihin. Free from waste products. And
the temperature requirements are being they also take care of the installation of
followed, and of course, the area where in equipment at paglalagay.
the materials and the ingredients needed ⚫ Maintenance of equipment
for the production are well taken care of. they take care of the calibration. Mga gamit
Not exposed to extremely hot or cold daw sa lab pinapaganyan. They have to
temperatures. They have to follow storage make sure that the equipment are well
requirements. calibrated because we all know that there is
⚫ Production Control a problem with the equipment, everything
will take care of the planning for the else might fail. Just imagine kung gaano
production of the products. kalaking problema ang mangyayare pag
⚫ Production nagkafailure sa equipment, kahit konting
In this area, they’re gonna start with the mali lang sa equipment pwedeng lahat
compounding. All the needed mixing, madamay (yung buong batch).
weighing, etc. That are needed to produce ⚫ Renders plant services
a pharmaceutical product. So everything ⚫ Maintenance of ground setting
that’s inside, for example sa syrup, yung ⚫ Hazard elimination
mixing, coloring, adding of colorant, adding
of flavoring, making it stable. Kumbaga STORAGE DEPARTMENT
yung nasa loob ng product is the apart from storage section of the production
production section’s responsibility. department, this one is for the storage of the
⚫ Packaging whole manufacturing.
will make sure that the inside is secured. Tasks
The packaging section will make sure that ⚫ Warehousing
the inside product is secured and safe. there are specific areas, example
Safe for transportation. warehouse 1, 2, okaya department A, B.
⚫ Shipping Just to make sure na may proper
so parang step by step process from segregation din.
procurement, storage, production control,
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⚫ Segregation In our course, if pharmacology is the heart of
of the materials, equipment, chemicals. our course, in the manufacturing firm, parang
They have to make sure that, for example ito ang pinaka heart nya.
mga chemicals, di dapat sya nakahalo sa
ibang gamit. Halimbawa humectants, mga Kase it all starts here.
bumabasa na ingredients, di dapat
isasama sa equipment na sensitive sa Pharmacists are badly needed in these areas.
humid. Walang production department kung walang
⚫ Organization research and development.
of different equipment and materials used
in the manufacturing firm. Very crucial din mapabilang daw sa department
na to pero fulfilling daw.
PURCHASING DEPARTMENT
Ito holistic din to, it is for the whole Kinds
manufacturing firm. ⚫ Pharmaceutical
Tasks so this covers the stability of the chemicals
⚫ Buying or the products that are being produced by
⚫ Checking of incoming materials the pharmaceutical manufacturing. Sila ang
⚫ Accounting responsible dyan.
they take care of the finances of the whole ⚫ Chemical
manufacturing firm. Sakanila yung financial takes care of chemical incompatibilities.
stability. ⚫ Physical
⚫ Inventory takes care of physical incompatibilities.
⚫ Public Relations ⚫ Radioactive
should there be any bidding, for example ⚫ Pharmacological
may binibili silang materials, equipment or ⚫ Clinical/Biological
ingredients, sila yung nakikipag usap sa
mga outside community, or kung saan sila Dapat maingat dito, kase if may mali daw
bibili. domino effect.

SALES DEPARTMENT In a pharmaceutical manufacturing firm, it is

Goal: to maximize or increase production important to be accurate and careful at all
turnover times.
In this department, you have to have a creative
mind in promoting and marketing. Our goal is, MISCELLANEOUS DEPARTMENT
(lahat ng manufacturing firm, kahit hindi naman Developmental Sections
pharmaceutical) mag increase yung sales for ⚫ Library
public consumption. ⚫ Offices
Tasks ⚫ Conference Areas
⚫ Detailing ⚫ Liaison Office
⚫ Promotion
dapat creative para mas mabenta Medical Section
⚫ Market Research ⚫ Treatment and check-ups of employees
halimbawa hindi gaanong mabili yung ⚫ Preparation of drug literature and
product, they will have a research on this. publications
Para malaman yung problema, bakit hindi
mabili ang product naten kumpara sa BASTA DOMINO DAW, STEP BY STEP
product ng iba. Example sa Covid-19 PROCESS. FROM PROCUREMENT,
vaccine kanya kanyang diskarte. PRODUCTION HANGGANG SA LABELLING,
⚫ Sponsorship DRUG LITERATURE, PRINTING OF DRUG
⚫ Package Design INSERTS. KASE SINASALI DIN ANG DRUG
INSERTS SA BOX OR SA FINAL PACKAGING.
RESEARCH AND DEVELOPMENT GALIT NA AKO.
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PILOT PLANT ACTIVITES Basta daw dapat responsible employees
tayo. Kahit daw sinasabi na nobody’s
Research and Development perfect, a mistake is never an excuse.
Purpose: Taray. Bawal magkamali dzai. Kaya dapat
⚫ To provide opportunities to scrutinize continuous ang re-evaluation from the raw
the formula and the process materials to the final product, (ex. from
very crucial to. When we say scrutinize, we phase 1 to phase 4 clinical trials).
mean to say, we have to have a detailed
inspection of the formula. This has Study of processing equipment
computation daw. Important Considerations:
⚫ To provide support from transition of ⚫ Use the most efficient and most
the product to large scale production consistent equipment but have an
interrelated with other departments of the alternative just in case.
company. For example, sa mga mixing equipment
⚫ To provide historical continuity palang, even if you think na it is the most
efficient equipment that you ever used,
*Interrelated with the other departments in the kailangan meron ka paring back up plan in
company case magkafailure yung equipment. Dapat
may alternative plan. Di pwedeng stop
operation pag may problema.
Review of the Formulations ⚫ The equipment should be suitable and
Purpose: relevant for possible scale up
⚫ To identify and establish all ingredients production
and their contribution to the final ⚫ The equipment may be customized and
product obtained from a reliable supplier
Sometimes, kahit inactive ingredient lang, so when you are responsible for the
through out the formulation, we discover na if it purchasing of equipment, you have to
is combine with the other inactive ingredients, it make a research. Reputable ba supplier,
may have other effects. Sabi ni calyx baka daw reliable ba sila, gumawa na ba sila ng mga
magka explosion. equipment before, maayos ba mga ginawa
nila, are there any problems encountered
Re-evaluation of raw materials by the previous laboratories na
Purpose: nagpurchase. Usually naman class for the
⚫ To approve and validate all ingredients marketing department ng mga nagbebenta
tignan kung wala ba talagang problema, ng equipment, the materials na ginagamit
lahat ba walang chemical and physical for the manufacturing firm, they have demo.
incompatibilities. Demo muna bago purchase.
⚫ To ensure and find out any problems ⚫ Consider the ease of cleaning especially
encountered in the transition from small if multiple products will use the same
scale to scale up production equipment
kase class there are some production na That’s very true kase kung halimbawa
for example, kapag small scale lang, konti pahirapan ang paglilinis, you will have a
ginagawa mo, walang nagiging problema. hard time. Lalo na if you use it multiple
Pero kapag bulk na nagkakaroon na ng times. Example, yujng analytical balance,
problem. Pwedeng with the mixing, or doon baka masyadong complicated tapos
mismo sa ingredients na ginagamit. Kaya gagamitin mo siyang madalas. Think a lot
may re-evaluation. Crucial din daw to. We of timmes before ka bumli ng complicated
know naman that in the manufacturing firm na equipment.
DITO NANAMAN NAG UUMPISA LAHAT. ⚫ Before purchasing the machine,
Kahit ano pang department ang pinili mong perform trial run/s within a supplier’s
pasukan, we all need the pharmaceutical vicinity.
manuf. Kase daw if walang gamot, pano ka Eto yung sinasabi nya daw kanina na, yung
mag ccommunity pharma. demo. And of course, after purchasing, ittry
/ run mo muna with the supplier’s
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supervision. Dapat andon pa sila, baka be organized. Kailangan nakaayos na yung
sabihin nila ikaw pa nagkamali sa paggamit. master formula, hindi pwedeng kapag
gagamitin mo, nasa production kana, doon
Pag you use an equipment, if you tried the ka pa mag ccram.
HPLC, basta yung mga mamahalin, dapat ⚫ To summarize raw material evaluations
mas maingat. Before performing a task,
you have to make sure to read the manual Transfer of the analytical methods to quality
very carefully. And wala namang masama assurance
sa magtatanong. Magtanong sa mga Purposes:
supervisors o doon sa mismong supplier. ⚫ To primary review the process, the
equipment, the raw materials, and the
Process Evaluation personnel keeping in mind large scale
Purposes: production
⚫ To facilitate transition Iba talaga yung hirap ng small scale at
⚫ To confirm the selected manufacturing large scale, kaya we have to review the
process to make a quality product whole process.
keeping in mind various critical stages ⚫ To rewrite/reformat all results into
that may affect the finished form understandable terms to be used in
CRUCIAL NANAMAN. Unless makita mo large scale production
daw yung final product, hindi pa tapos ang So if there are any modifications, like may
struggle ng isang pharmacist. natuklasan ka, if I mix this ingredient with
another ingredient, it will have this effect.
Parameters to be evaluated in Process TAKE NOTE OF THOSE.
Evaluation If you discovered an easier way to ease up
⚫ Order of addition of ingredients the process, mas mabili tas parehas lang
⚫ Mixing speed naman yung magiging effect, you have to
Hindi ibig sabihin na lahat ng liquid pwede write or reformat. Wag maging madamot
mong paghaluhaluin in the order or manner dito. Share the secret. Minsan may
that you want. nalaman ka tas serendipitous lang, you can
We have to consider also the mixing speed. suggest okaya review kung may
There are ingredients na kapag yung nangyaring kakaiba.
speed ng mixing mo is mas mabilis,
pwedeng mas maging viscous sya okaya
naman magkaroon ng any physical
incompatibility, precipitation.
⚫ Heating and cooling rates of
temperatures
You have to make sure na yung cooling
process gradual. Hindi pwedeng dahil
nagmamadali ka ilalagay mo sa ref. Bawal
daw yon sa practice.
⚫ Mesh sizes
You have to make sure na tama yung mesh
size. The particle size varies. Pag may
variation, the effect may also vary.
⚫ Drying temp. and drying time

Preparation of the master process and

formula
Purposes:
⚫ To summarize process and equipment
Dito, hindi pwede yung mga nagccram or
mga hindi organized. When you are in the
manufaturing industry, everything should