New Manufacturing-Bulk and Sterile

Manufacturing-Bulk and Sterile
Lecture # 1
By
Imran Ahsan Mallick
Learning objectives
At the end, the students will be able to know and

describe about manufacturing bulk formulations in
hospitals
Introduction
In house preparation categories:
Bulk compounding
Non sterile drug preparation
Sterile manufacturing
Bulk compounding is not commercially available and
modified formulations for clinical or investigational use
Sterile manufacturing is used for preparing sterile
topical solution, small volume injectable, special
products for clinical or investigational use, IV
admixtures and TPNs in hospitals
Benefits
Hospital pharmacist & physician close relations
Economical
Complimenting formulary
Availability of drugs not commercially available
Drugs available for unusual illness
Development of new preparation for research or
clinical use
Enhancing pharmacist’s prestige
Definitions
Standards: models against which a procedure or
product is matched and against which the acceptability
of material or procedure are to be judged
Control: testing & verification of a procedure and
product against certain standards; To exercise careful
restraining power over various manufacturing
processes to achieve product of required specifications
cGMPs followed with reference to premises,
environment, men, methods, machines,
documentation, etc
Control systems
Manufacturing process control
Quality control
Budgetary control
Manufacturing process control
High standard products required
Product accuracy in identity, strength, purity and
quality
Packaging & labeling controls
Adequate Stability, palatability, packaging and labeling
C GMPs followed
Quality control
Quality contributes to performance of an intended
function when it is used as directed
Quality control implies procedures by which decision
can be made whether a product is meeting standards
established previously
Corrective actions required at times
Quality control is a series of tests, analysis and
observations to establish identity, quality and quantity
of product and to assess its safety, purity & efficacy
Contd..
Categories of quality control in pharmacy department
Quality control of raw material
Quality control of instruments
Quality control of area
Quality control of finished products
Budgetary control
Regulates economic aspects
Requires careful planning for requirements of:
Manufacturing
Raw materials
Manufacturing capacity
Available personnel
Operating costs (direct & indirect)
Maintenance of manufacturing equipment
Its control over equipment operation
Equipment maintenance program required for lowest
possible repair cost
Pharmacist is responsible for maintenance program
Equipment maintenance record required
Thanks
Any questions?
Reference
Pages 92-101, Hospital Pharmacy, N. I. Bukhari
Further reading:
Pages 425-460, Hospital Pharmacy, W. E. Hassan
Lecture # 2
By
Imran Ahsan Mallick
Learning objectives

describe about GMP regulations in hospitals
Organization and personnel
Responsibilities of QC unit
Personnel qualification & responsibilities
Buildings & facilities
Design & construction
Lighting, ventilation
Sewage
Sanitation
Maintenance
Equipment
Design, size and location
Cleaning & maintenance
Types
Filters
Control of components and drug product
containers & closures
Storage of untested items

Testing, approval, rejection
Production & process controls
Procedures & deviations
Charge in of components
Yield calculation
Equipment identification
Sampling & testing of in-process materials & products
Microbial contamination control
Reprocessing
Packaging & labeling control
Material examination & usage criteria
Labeling issuance & operations
Drug product inspection
Expiration
Holding & distribution
Warehousing
Distribution
Lab controls
General requirements
Testing & release for distribution
Stability testing
Reserve samples
Lab animals
Records & reports
General requirements
Equipment cleaning & log
Component, container, closure & labeling records
Master production & control records
Batch/ lot production & control records
Record review
Lab records
Distribution records
Complaint files
Returned & salvaged drug products
Returned products
Product salvaging
Thanks
Any questions?
Reference
Further reading:
Lecture # 3
By
Imran Ahsan Mallick
Learning objectives

describe about sterile manufacturing in hospitals
Sterile manufacturing
More stringent specifications
Sterility
A pyrogenicity
Additional environmental controls
Components: IV additive program & IV additive
services
IV additive program
Policies & procedures for preparation & administration
of IV fluids to which drugs are to be added under
aseptic conditions
Drugs incorporated under sterile conditions
IV additive service is a part; refers only to product
preparation
Pharmacist: prepares final product aseptically, chooses
additive & mixing techniques to avoid interaction,
labels/ dispenses/ stores final product appropriately
IV additive service
A part of iv additive program
Preparation of final product under aseptic conditions
Choice of additive and mixing techniques to avoid
interactions
Laminar flow hoods
Laminar air flow is air movement with uniform
velocity along parallel flow lines
LAF hood is a cabinet with constant outward flow of
micro filtered air, creating aseptic and sterilized
environment
Commercially available
Two types: horizontal & vertical
Preparation & dispensing of IV additive
solutions
Physician’s order
Label preparation
Ancillary label may be required
Label affixed upside down
Prepared under LAF hood
Final inspection of preparation
Areas of knowledge for IV solution
preparation
Understanding of parenteral feeding therapy
Acid base balance
Nitrogen balance
Fluid electrolyte therapy
Metabolic & mechanical complications
TPN
Drug nutrient & drug lab test interactions
Current standards & recommendations followed
Eg. Parenteral hyperalimentation & cytotoxic drugs
Parenteral hyperalimentation (TPN)
IV administration of sufficient nutrients above usual
basal requirements to achieve tissue synthesis, positive
nitrogen balance and anabolism to tolerate any form of
enteral feeding for long term
Part of total care for any patient & integral part of
pharmacy ‘s manufacturing program of any size
Stability & compatibility
Facility & environment
Personnel & training
Documentation
Contd..
Manufacturing procedures
Collection of materials & preparation
Formulation
Inspection
Labeling
Storage
Packaging
Dispensing
TPN charging
Indications for TPN
Pre and post operative support
Malignancy
Inflammatory bowel disease
Pancreatitis
Severe trauma
Burns
Sepsis
Hepatic and renal failure, etc
Cytotoxic agents
Capable of killing cells
Mostly powder preparation; require re constitution
Pharmacists & technicians: well trained in aseptic
techniques, recording & checking procedures
Classification of cytotoxic agents
Alkylating: cyclophosphamide, chlorambucil
Antimetabolites: methotrexate, 5 fluorouracil
Vinca alkaloids: vincristine, vinblastine
Antitumor/antibiotic: doxorubicin, epirubicin
Miscellaneous: dacarbazine, cisplatin
Areas of skill needed for pharmacist
Safe handling
Preparation areas
Techniques & precautions
Prevention of aerosol formation from cytotoxic vials
Coping with spills and waste disposal
Disposal
Thanks
Any questions?
Reference
Further reading:

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Manufacturing-Bulk and Sterile

At the end, the students will be able to know and

At the end, the students will be able to know and

Storage of untested items

At the end, the students will be able to know and

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