All the processes regarding concerned drug are performed on these three batches.

After checking the results the average of results from these batches is taken and data

will be compiled. This process results in formation of various documents like SOPs for

machines, record books, etc. After validation batches, the large-scale production of

the product will be done.

For implementing efficient documentation practices, here is a suggestion which

mentions the areas required for GMP document implementation. These below

mentioned areas provide only guidance and should not be treated as maximum criteria

for documentation. Any other document not on the list will be included if helps in

improving the quality of products.

i. Design and development reports

ii. Distribution records

iii. Operational procedures/techniques/methods, out of specifications (OOS), out

of trend (OOT),

Fig. 2.5: Stepwise flow of products from small-scale batches to full-scale batches

General Considerations and Pilot-Plant Considerations for Different Dosage Forms 23

iv. User requirement specifications and utilities like water systems, HVAC, AHU,

etc.

v. Dossiers and Drug Master Files for regulated markets

vi. Man, materials, machines, methods, maintenance, manufacturing operations and

controls

vii. Cleaning and calibration records and reports

viii. Containers and closures analysis report, contamination and change control,

ix. Monitoring, master formula, manuals (quality, safety and environment), medical

records

x. Engineering control and practices

xi. Environment control

xii. New products and substances

xiii. Technology transfer

xiv. Training

xv. SOPs, supplier qualification, specifications and standard test procedures

xvi. Site master file (quality assurance)

xvii. Stability studies reports, quality risk management report

xviii.Validation reports, qualification reports, analytical method transfer reports

xix. Notices, circulars, amendments, complaints details, entry–exit details, trend

analysis report

xx. Safety practices, sanitation, storage, self-inspection, standardization,

xxi. Documents mentioning roles and responsibilities of personnel working at the

facility with their qualification and other details.

PRACTICE QUESTIONS

Long Answer Type Questions

1. Describe pilot-plant scale-up consideration for solids in detail.

2. Describe pilot-plant scale-up considerations for semisolids and oral-liquids in detail.

3. Explain general consideration under pilot-plant studies.