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 Analytical Control Laboratory (ACL) 

 ACL is that part of QC unit which is responsible for :
- Heart of Quality management in Pharmaceuticals
1- Testing and approving or rejecting raw materials (active or inactive)
2- work in process control at critical operation steps
3- Testing and approving or rejecting finished product
 Requirement of ACL:
1- Staffed with trained personnel , experienced → perform complex analysis required to evaluate
acceptance of a product
2- Well equipped with instruments → allow accurate analysis
3- Detailed specifications of test methods must be available (specifications must include limits for
acceptance or rejection for each parameter)
 In process control and validation :
- In process control is identified at the critical operational steps
- In process limits (alert or action levels ) are
a) limits or specification more restrictive than final acceptance level
b) giving early warning of conditions which lead to out of control situation
c) allow timely corrective action to be taken before this occurs.
- In process critical testing depends on dosage form being manufactured
- Sterile products receive the most critical in process control and testing → to insure finished
product is sterile and free of microbial contamination.
 Validation of operations is defined as :
- Assurance that production processes are controlled in such manner that will perform routinely in
the manner in which they are planned to
- Validation of processes systems and in process control gives ↑ assurance of finished product lot
quality and leading the way toward reducing or eliminating reliance of end product testing.
• Drug standards •
- Standards of quality for drugs such as : chemical , physical , microbiological , pharmacological
characteristics
1- Pharmacopoeial drugs : pharmacopoeial monograph contains statement of minimum standards
with which the individual drug must comply
2- Non-official drugs : product license issued by national regulatory authorities should include
statement of standards (product specification)
- Source of drug standards (accepted values)
Official - accepted pharmacopoeia standards - international (IP) published by WHO
- Regional European P (Eur.Ph) - National : EP , BP , USP
Non official - manufacturer approved standards

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• Drug monograph contains information on :
- drug standards - quality characteristics
- detailed test methods of analysis (qualitative identification and quantitative determination) which
must include the limits of acceptance or rejection
• Many drugs fail to conform to required standards due to : ‫ال تتوافق العديد من األدويه مع المعايير المطلوبة بسبب‬
1. Inadequate product development (is unstable)
2. Properly developed drug with good stability subjected to proper storage conditions, has been
exposed to excessive humidity or beat.
3. Defective packaging may result in deterioration of drug.
4. Careless manufacturers and neglect of code of GMP
5. Deficient in active ingredients
6. drug may contain correct amount of active ingredient, but this may not be released on
administration (not bioavailable )
7. drug may be produced on unlicensed premises ‫أماكن غير مرخصه‬
• In order to reduce hazards of sub standards drugs to very Iow Ievel :
- it is necessary for every nation, every factory to have effective means to detect sub-standard
drugs and to take effective action either :
a) To prevent their production at factory level
b) To remove them from market
• Development of ACL •
 In setting up laboratory , one must be :
1- To ensure that there is pharmacy administration → constituted to provide required administrative
framework
2- To define objectives in terms of drugs to be tested and types of test to be applied
3- To outline sampling schemes which will ensure optimal use of laboratory resources
- The objective must be to establish laboratory which is competent , self-confident , respected
 Technical competence ‫ الكفاءة الفنية‬:
- will be attained only after several years (Phased) by:
a) introducing new techniques ‫ادخال تقنيات جديدة‬
b) associated equipment at rate which permits sound degree of experience to be gained before
proceeding to next step.
 Methods of investigation in ACL:
- Physicochemical methods as IR, UV –Vis spectroscopy , chromatography , …
- Assessment of purity - Assay - Physical criteria - stability

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• Development of ACL •
1- • It is desirable to have at least 500 sqm ‫ → متر مربع‬to house chemicals and
physico chemical testing facilities as follows :
Accommodations
- Rooms for chief analyst and consultants
- Documentation and sample room - Registry room - Library
- stores (chemicals , glassware , spares , consumable of instruments )
- General laboratory for routine chemical and preparative work for instrumental
analysis accommodated with fuming hood , distillation apparatus , water
bathes , balance , drying oven , vacuum oven , disintegration unit , dissolution
unit , centrifuge , TLC tank
- instruments room for housing the listed instruments
2- - The indicated space of about 500 sqm will need at least 100 meters length of
laboratory benches fitted with cupboards (some of these benches should
Laboratory
include laboratory sinks )
furniture and
fixture - When ordering equipment :
requirements for equipment are listed in three stages :
1st stage - list of equipment to be obtained before analysts assume their
duties.
2nd stage - list of equipment to be ordered in first year
3rd stage - list of equipment to be ordered in second year
- in 3rd year full utilization of all equipment should be achieved
3- Chemicals & - list of immediate requirements should be ordered depending on items
glassware selected for test.
4- Books & - Required books and journals are listed and should be ordered according to
journals laboratory work
5- Staffing & - The qualities required for successful analyst are :
manpower a) Good basic academic background , critical mind , develop his knowledge
development
and technical skills
b) All analyst and technicians should receive training during work with
consultant and chief analyst
c) Some staff could be sent abroad → gain further experience & qualifications
6- Ancillary staff - Secretarial staff are needed for maintenance of documents and smooth
administration
‫طاقم مساعد‬
7- Lab - For smooth and efficient work of laboratory it is necessary to
organization and a) follow instructions of standard operating procedures (SOP) ‫اجراءات التشغيل‬
administration ‫الموحده‬
b) All persons working in laboratory should have clear job description

Dr.Baher 01222578887