IPS 2: MANUFACTURING

Manufacturing

the complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished product.

raw materials and packaging materials

what are the main materials used in manufacturing

Manufacturing

The manufacture, propagation, preparation, compounding or processing of a drug product in a large scale.

drug establishment

Any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines

drug manufacturer

Any establishment engaged in operations involved in the production of drugs

prescription drugs

what does ethical manufacturers focuses on

branded or generic drugs

what does propriety manufacturers focuses on

vaccines, toxoids, antisera, biotech products

what does biologicals manufacturers focuses on

produces drug for other companies

what do toll/contract manufacturers do

Drug Distributor/Importer/Exporter

Imports or exports raw materials, active ingredients or finished products for its own use or for wholesale distribution on wholesale basis

Drug Distributor –Wholesaler

Procures raw materials , active ingredients and or finished product from local establishment or for local distribution on wholesale basis

Drug trader

Registered owner of the drug product but subcontracts toll manufacture of such products to a licensed manufacturer. May also engage in distribution and or marketing of products

Drug

Intended for and having as their main use the diagnosis, mitigation, treatment, cure or prevention of disease in man and other animals

Pharmaceutical preparation

Means of administering drugs as formulated preparations

Dosage form

Combination of an active ingredients and additive

Drug products

Finished dosage form that contains an active drug ingredient, generally, but not necessarily, in association with inactive ingredients

batch

A specific quantity of a drug or other material that is intended to have uniform character and quality

Lot

A batch or a specific identified portion of a batch

Lot Number/ Control Number/ Batch Number

Any distinctive combination of letters, numbers or symbols from which the complete history of the manufacture can be determined

Active ingredient

Any component that is intended to furnish pharmacological activity

pharmaceutical excipient

Any component other than an active ingredient

quarantine

An area that is marked, designated or set aside for the holding of incoming components prior to acceptance examination

component

Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such product

in-process method

Any material fabricated, compounded, blended or derived by chemical reaction that is produced for, and used in, the preparation of the drug product

master records

Ensure that batches were properly made, and QC tests were performed

theoretical yield

The quantity that would be produced at any appropriate phase of manufacturing based upon the quantity of raw material used

actual yield

Quantity that is actually produced at any appropriate phase of manufacturing, processing, or packing of a particular drug product

master formula

Contains formulations, manufacturing procedures, specifications, QA requirements and labeling of a finished product

monograph

Document that specifies all the tests to be conducted on a product and/or appropriate references containing details of procedure and expected resul

Certificate of analysis

Document with the results of all tests conducted on material to show compliance or non- compliance with the standard specifications

raw material specification

This should enumerate the characteristics of all the materials that go into the product and the permissible range of purity of each ingredient.

formula

This is concise and precise statement of the ingredients that comprise the product, together with the percentage and/or weight of each.

standard operating procedure

This is a step by step method on how to go about a job.

Finished product specification

This should cover all characteristics that affect the proper performance, purity, safety and stability of the product.

sample

Finite number of objects selected from a batch

planning and scheduling division

purchasing section

inventory section

sections under the production division

purchasing

In charge of purchasing requisitioned material (both packaging materials and raw materials), both from local and imported sources

Inventory control

Watches and monitors closely. Records all materials used in the production; Controls the stocks of both raw materials, packaging materials and finished products. In charge of checking stocks PERIODICALLY

Planning and Scheduling

Coordinates with the marketing department on what products are required for supply. Plans and Schedules the *manufacture of the products

raw material

in-process section

finished goods area

returned goods area

dispensing section

sections and areas under warehouse division

quarantined materials

yellow coded labels, materials are subject to tests and assays by the quality control section and are not yet to be used

approved for use materials

green coded labels, materials that conform to the standards and specification.

rejected materials

red coded stickers, materials that are found to be substandard. These materials are either returned to the supplier (for replacement) or disposed of properly.

in process section

Consists of products which have been bottled, stripped or packed, but not yet labelled or packed into boxes or cartons. Under Quarantine

finished products or goods

Contains the products packaged and finished and are ready for distribution and sale.

returned goods

The products returned are stored in this section of the warehouse

dispensing section

Area where raw materials for use in the production are weighed and/or measured. The packaging materials are also counted upon issuance.

engineering and maintenance section

Takes charge of the care, maintenance and repair of all machines and equipment used in the plant department, including electrical lines, water and sewerage systems, waste management, telecommunication lines and environment sanitation, etc.

Research Department (locally) Parent Company (abroad)

in charge personnel in preparing the master formula

name of the product

potency of the active ingredient

batch size, amount yield

list of ingredients and specifications, including code number

quantity of each ingredient

signature of the competent people who prepared the MF

master formula consists of what (6)

Quality control head

Preparation of the Master formula if the master formula is not the actual amount to be manufactured, who is in-charge of that

production control

in charge personnel for the Preparation of Manufacturing Order (MO) and Finishing order.

pharmacist in dispensing area

Weighs/measures the ingredients, counts the packaging materials and transfer them to the manufacturing and packaging area respectively.

compounding pharmacist

Compounds the product, according to the standard compounding procedures

quality control

While the product is processed, it undergoes in process tests.

compounded product

is transferred to the packaging section where it is bottled/stripped or packed.

packaging section

Transferring the bottled, stripped or packed products to what area

packaging section

If the in-process tests are approved by the Quality control, the warehouse In charged. bottled/stripped/packed products are labelled, packed into unit boxes then to cartons by what section?

finished goods

The finished products are transferred in the ____________area of the warehouse ready for distribution and sale.

CGMP

Were established to ensure that LESSON 3 minimum standards are met for drug product quality

quality

It refers to the perception of the degree to which the product or service meets the customer's expectations

GMP

Part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use

GMP

System of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for intended use and is concerned with manufacturing and quality control process and procedures

quality assurance

The sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use

quality assurance

It is a wide-ranging concept which covers all matters which individually or collectively influence the quality of a product

•AO 43 s 1999

adoption of the 1st edition of the Current Good Manufacturing Practice Guidelines by the Bureau of Food and Drugs

AO 2012-0008

adoption and implementation of the PIC/S GMP as the standard on the manufacture of pharmaceutical products

FDA MC 2012-004

Philippine FDA mandated all drug manufacturers to ensure strict and full compliance to the newly adopted PIC/S GMP

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

PIC/S meaning

specification.

All manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their _______

validated

.Critical steps of manufacturing process and significant changes to the process is what?

a. appropriately qualified and trained personnel

b. adequate premises and space

c. Suitable equipment and services

d. Correct materials, containers and labels

e. Approved procedures and instruction

f. Suitable storage and transport

All necessary facilities for GMP are provided including (6)

unambiguous

Instructions and procedures are written in an instructional form in an ____________ language specifically applicable to the facilities provided

operators

are trained to carry out procedures correctly

records

are made, manually and or by recording intriments, during manufacture which demonstrates that all the step required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected.

deviations

Any significant _______are fully recorded and investigated

distribution

Records of manufacture including _________ which enable the complete history of a batch to be traced are retained in a comprehensible and accessible form

distribution

The________(wholesaling) of the products minimizes any risk to their quality

A system

should be available to recall any batch of product from sale or supply

Complaints

________ about marketed products are examined The cause of quality defects investigated, and appropriate measures taken in respect of the defective products and to prevent reoccurrence

ensure product quality and safety

promotes consistency in manufacturing

prevents contamination and mis-ups

ensures proper documentation and traceability

strengthen quality assurance and quality control systems

protects public health

supports regulatory compliance

enhance professional accountability

Importance of the provisions of cGMP (8)

Packaging

An economical means of providing presentation, protection, preservation, identification, information, containment, convenience and compliance for a drug product

container

Device that holds a drug and is or may be in direct contact with the drug

primary packaging

Immediate Container, direct contact, direct effect on the drug

secondary packaging

external to the primary container, adds physical protection

Well-closed Container

protects against extraneous solids and loss of drug under ordinary conditions of handling, shipment, storage and distribution

Tight Container

protects from extraneous solids, liquids or vapors, from loss of drug and from efflorescence, deliquescence or evaporation and loss of drug under ordinary conditions of handling, shipment, storage and distribution

Hermetic container

impervious to air or any other gases under ordinary conditions of handling, shipment, storage and distribution, generally sterile

Light resistant container

protects the contents from photochemical deterioration amber, opaque, blue

single-unit container

designed to hold a quantity of drug intended for administration as a single dose. sterility is not assured after opening

multiple unit container

contains more than a single dose of the medication

highly resistant borosilicate glass

Type I glass

for parenterals

type I glass use

powdered glass

type I test

treated soda lime glass

type II glass

for parenterals

type II glass uses

water attack

type II glass test

soda lime glass

type III glass