Batch Record Documentation Preparation

Batch manufacturing in the pharmaceutical industry involves the production of

medicines in specific quantities or batches, which are then subjected to quality
control measures to ensure consistency, safety, and efficacy. Here's how batch
manufacturing is typically recorded in pharmaceuticals:

 Reference – Batch Manufacturing Records (BMR)

 The Rules Governing Medicinal Products in the European Union : Volume 4,

 EUGMP Medicinal Products for Human and Veterinary Use. Chapter 4:
Documentation
 Drug and cosmetic Act : Schedule M

 Content of Master Formula Record (MFR)

 MFR shall contain the steps of manufacturing & primary packing to provide
the guidance for preparation of BMR & BPR.
 The Master Formula Record shall be prepared in approved format.
 The format of MFR will be valid as per old format & shall be revised with
new format when there is any change.
 The MFR shall have the following details but not limited to:
 General Information
 Pre-Manufacturing controls and Precautions
 Weighment Sheet of Raw Materials
 Details of Packing Material
 List of Equipment’s
 Flow Charts
 Dispensing of Raw Materials
 Manufacturing Process
 Packing Process
 Quality Checks
 Batch Record Documentation Preparation
 Revision history

 Content of the Batch Manufacturing Records (BMR)

 BMR shall contain the steps of manufacturing as stated in the Master

Formula records with
provisions for recording the time of performing the activity and signature of
the responsible
 The Batch Manufacturing Record shall be prepared on approved format i.e.
for
own product & LL product.
 The format of Batch Manufacturing Record (BMR) will be valid as per old
format & shall be revised with new format when
there is any change.
 The BMR shall have the following details:
 Cover page shall have the complete details of product being
manufactured.
 Check list
 Raw material dispensing & weighing records.
 Calculation for quantity of active ingredient(s) according to their assay &
LOD/water.
 Line clearance provision.
 Complete stage wise details of manufacturing operation.
 Release details for packing.
 Yield calculation
 Specimen signature log

Remarks: For existing documents, shall be issued till next revision of

respective BMR.
 Batch Record Documentation Preparation
 Batch Manufacturing Record (BMR) contains manufacturing activities for
tablets like –
 Drying,
 Mixing,
 Granulation,
 Compression,
 Coating and
 Inspection process with the provisions of recording time of performing
activity and initial of the responsible person.
 Batch Manufacturing Record (BMR) contains manufacturing activities for
capsules like-
 Drying,
 Mixing,
 Filling and
 Inspection process with the provisions of recording time of performing
activity and initial of the responsible person.
 Batch Manufacturing Record (BMR) contains manufacturing activities for
liquid syrup like
 Syrup preparation,
 Filtration/homogenization,
 Filling,
 Sealing,
 Inspection process, &
 Packing with the provisions of recording time of performing activity and
initial of the responsible person.
 Batch yield details.
 Batch Record Documentation Preparation
 Content of the Batch Packaging Records (BPR):

 Batch Packaging Record (BPR) shall contain the steps of primary packing
as stated in the Master Formula records with provisions for recording the
time of performing the activity and signature of the responsible person.
 The format of the Batch packing Record shall be prepared on approved
format.
 The format of Batch Packaging Record (BPR) will be valid as per old
format & shall be revised with new format when there is any change.
 The part of the Batch Packaging Record (BPR) shall have the following
details:
 Cover page shall have the complete details of product under packing
operation.
 Check list
 Packing material details.
 Packing operation & instruction
 Line Clearance Checks
 In-process record for overprinting of the primary, secondary & tertiary
packaging materials
 In-process record for packing operation of primary, secondary & tertiary
packaging materials.
 C-box weighing records
 Packaging material reconciliation record
 Yield calculation
 Deviation
 Specimen signature log

Remarks: For existing documents, shall be issued till next revision of

respective BPR.
 Batch Record Documentation Preparation


 The master copy of Batch Manufacturing Record (BMR)/BPR shall be

printed on A4 size paper, the font style of the text matter shall be “Arial”
and the font size shall be “11”.
 For the tabular representation the font size may be reduced but not less than
10.
 Page number is assigned to each page of the BMR and BPR.
 The page number shall be in the form of X of Y; where X stands for the
first page and Y stands for the total no. of pages in that particular part of the
BMR and BPR.

 Preparation, checking, and approval of Master Formula Record (MFR)/

Batch Manufacturing Records (BMR)/ Batch Packaging Records (BPR)

 For MFR:

 PDL Chemist shall prepare MFR based on the R&D document & forward
to Head PDL for checking.
 QA shall check & send the signed MFR to Head QA for approval.
 Prior to approval, any points required to be rectified or shall be amended.
 Signatures with Date & Name of the Prepared by, checked by, approved by
& authorized by shall be made on first page of the MFR and remaining
preceding pages of MFR only sign & date of Prepared by, checked by and
approved.

 For BMR/BPR:

 Production Chemist and above shall prepare Batch Manufacturing Record

(BMR)/BPR based on the MFR & forward to Head Production / Designee
for checking.
 Batch Record Documentation Preparation
 After checking Officer Production shall do the corrections if any & print the
Batch Manufacturing Record (BMR) / BPR and send the signed document
to QA for approval.
 Head QA shall approve the Batch Manufacturing Record (BMR) /BPR.
 Prior to approval, any points required to be rectified or shall be amended.
 Signatures with Date & Name of the Prepared by (Production Chemist and
above), checked by (Production Executive and above), approved by (Head
Production & Head QA) shall be made on BMR/BPR as per annexure-II &
III (For EU Products).
 Whenever any customer signature to be required in the Master BMR/BPR
same shall be incorporated under the Approved by column.
 For scale up batches the master BMR shall be prepared as per the
Annexure-IV.
 PDL shall prepare & check the scale-up BMR and shall be approved by
Head QA.

1. Batch Record Documentation: Each batch of pharmaceutical products

manufactured undergoes stringent documentation procedures. This includes
creating a batch record or batch production record (BPR). The BPR is a detailed
document that provides step-by-step instructions for the production process. It
includes information such as:
 Batch number: A unique identifier assigned to each batch.
 Date and time of production: Recording when the production process started
and ended.
 Raw materials used: Detailed list of all ingredients, including their quantities,
lot numbers, and expiration dates.
 Batch Record Documentation Preparation
 Manufacturing procedures: Step-by-step instructions for each stage of
production, including mixing, blending, granulation, compression, coating, and
packaging.
 In-process controls: Checks and tests conducted during production to ensure
quality and compliance with specifications.
 Environmental conditions: Recording of parameters such as temperature,
humidity, and pressure during manufacturing.
 Equipment used: Documentation of the machinery and equipment used in the
production process, including calibration records.
 Personnel involved: Identification of the operators and supervisors responsible
for each stage of production.
2. Quality Control and Assurance: Throughout the manufacturing process,
samples are taken at various stages to assess quality and ensure compliance with
regulatory standards. These samples are tested for parameters such as potency,
purity, dissolution rate, and microbiological contamination. The results of these
tests are recorded in the batch record, along with any deviations from the
expected specifications and corrective actions taken.
3. Review and Approval: Once the production process is complete, the batch
record undergoes review and approval by designated personnel, such as quality
assurance officers and production managers. This ensures that all steps were
followed correctly and that the batch meets the required quality standards before
release for distribution.
4. Archiving and Traceability: Batch records are typically retained for a
specified period (often several years) as part of regulatory requirements. This
allows for traceability and investigation in case of product recalls, complaints,
or regulatory inspections.
 Batch Record Documentation Preparation
 Granulation parameter

Granulation is a process used in pharmaceutical manufacturing to improve the

flow properties, compressibility, and uniformity of powdered materials, making
them suitable for tablet compression. Various parameters are considered during
the granulation process to achieve the desired product characteristics. Here are
some key granulation parameters:

1. Binder Solution: The choice of binder solution and its concentration play a
crucial role in granulation. Binders like water, alcohol, or solutions of polymers
like hydroxypropyl cellulose (HPC) or hydroxypropyl methylcellulose (HPMC)
are used to bind the powder particles together. The concentration of the binder
solution affects the wetting ability and adhesive properties, influencing the
granule size and strength.
2. Granulating Agent: Granulating agents are often added to facilitate granule
formation. Common granulating agents include starch paste, gelatin solutions,
and cellulose derivatives. These agents improve the binding properties of the
binder solution and help in the formation of cohesive granules.
3. Particle Size Distribution: The particle size distribution of the raw materials
affects the characteristics of the granules. A wide particle size distribution can
lead to uneven granule size and poor flow properties. Therefore, controlling the
particle size distribution of the starting materials is essential for uniform
granulation.
4. Granulation Method: Different granulation methods, such as wet granulation,
dry granulation (e.g., roller compaction), and direct compression, have specific
parameters that influence the granule properties. For instance, in wet
granulation, parameters such as mixing time, impeller speed, and wet massing
time affect granule size, density, and uniformity.
 Batch Record Documentation Preparation
5. Moisture Content: Proper control of moisture content is critical during wet
granulation to achieve optimal granule formation and prevent overwetting or
under wetting. The moisture content influences the granule size, density, and
strength.
6. Drying Conditions: After granulation, drying is necessary to remove excess
moisture and stabilize the granules. Drying parameters such as temperature,
airflow rate, and drying time impact the final moisture content and physical
properties of the granules.
7. Screen Size: If the granulation process involves milling or sizing, the screen
size of the mill or sieve used affects the granule size distribution.

By carefully controlling these granulation parameters, pharmaceutical

manufacturers can produce granules with the desired characteristics, leading to
high-quality tablets with consistent performance and efficacy.

 Compression parameter

Compression parameters refer to the factors and conditions involved in the

compression process during tablet manufacturing. These parameters are crucial
for ensuring the quality, consistency, and performance of the tablets produced.
Here are some key compression parameters:

1. Compression Force: Compression force, also known as compaction pressure, is

the force applied to the powder blend during tablet compression. It determines
the tablet hardness, which affects disintegration and dissolution rates. Higher
compression forces result in harder tablets with slower disintegration, while lower
forces may lead to softer tablets with faster disintegration.
2. Tablet Thickness: Tablet thickness is controlled by adjusting the compression
force and the fill volume of the die cavity. It influences tablet appearance, weight
 Batch Record Documentation Preparation
uniformity, and ease of swallowing. Consistent tablet thickness is essential for
dosage accuracy and packaging.
3. Tablet Diameter: Tablet diameter is determined by the size and shape of the die
cavity. It affects tablet appearance, uniformity, and swallowability. The tablet
diameter should be within specified limits to ensure dosage accuracy and
packaging compatibility.
4. Tablet Weight: the fill volume of the die cavity and the density of the powder
blend primarily influence Tablet weight. It is critical for dosage accuracy and
uniformity. Proper control of tablet weight ensures that each tablet delivers the
intended dose of the active pharmaceutical ingredient (API).
5. Tablet Hardness: Tablet hardness, also known as tablet breaking strength or
crushing strength, measures the force required to break a tablet. It is influenced
by the compression force, particle size distribution, and binder properties. Tablet
hardness affects tablet friability, disintegration, and dissolution rates.
6. Tablet Friability: Tablet friability refers to the tendency of tablets to chip, break,
or crumble when subjected to mechanical stress during handling or transportation.
It is assessed by subjecting a sample of tablets to tumbling in a friability tester.
Compression parameters such as compression force and tablet hardness influence
tablet friability.
7. Ejection Force: Ejection force is the force required to eject the tablets from the
die cavity after compression. It is influenced by factors such as tablet design, die
wall lubrication, and tablet surface properties. Excessive ejection force can lead
to tablet sticking or capping, while insufficient force can result in incomplete
tablet ejection.
8. Compression Speed: Compression speed, or tableting speed, refers to the rate at
which the punches compress the powder blend into tablets. It affects tablet
properties such as hardness, disintegration, and content uniformity. Optimal
compression speed depends on the characteristics of the powder blend and the
equipment used.
 Batch Record Documentation Preparation
9. Tablet Weight Uniformity: Tablet weight uniformity ensures that each tablet
in a batch contains the correct amount of active pharmaceutical ingredient (API)
and excipients. It is determined by weighing a sample of tablets and calculating
the weight variation relative to the average tablet weight. Tablet weight
uniformity testing is essential for ensuring dosage accuracy and compliance
with regulatory requirements.
10. Disintegration Time: Tablet disintegration time is the time it takes for a tablet
to disintegrate into smaller particles when immersed in a specified volume of
dissolution medium. Disintegration testing provides information on the ability
of a tablet to break apart and release its contents for dissolution and absorption
in the body.
11. Dissolution Rate: Dissolution testing measures the rate at which the active
pharmaceutical ingredient (API) is released from the tablet and dissolves in a
specified dissolution medium. Dissolution testing provides information on the
drug release profile and bioavailability of the tablet formulation.
12. Moisture Content: Moisture content testing measures the amount of moisture
present in the tablet formulation. Excessive moisture can affect tablet stability,
dissolution, and physical properties. Moisture content testing helps ensure that
tablets meet specified moisture limits and remain stable throughout their shelf
life.

 Coating stage parameter

The coating stage in pharmaceutical manufacturing involves applying a thin

layer of coating material onto tablets or granules to achieve various objectives,
such as masking taste, protecting from moisture or light, controlling drug
release, or improving appearance. Several parameters are considered during the
 Batch Record Documentation Preparation
coating stage to ensure the quality, uniformity, and functionality of the coated
products. Here are some key parameters:

1. Coating Solution Composition: The composition of the coating solution is

critical and may include polymers (e.g., cellulose derivatives like
hydroxypropyl methylcellulose or HPMC, polyvinyl alcohol, acrylic polymers),
plasticizers (e.g., polyethylene glycol or PEG), colorants, opacifiers, and other
excipients. The selection and concentration of these components influence
coating adhesion, flexibility, solubility, and appearance.
2. Coating Solution Properties: Properties such as viscosity, surface tension,
density, and solids content of the coating solution affect its flow, wetting, and
spreading characteristics. Proper control of these properties ensures uniform
coating application and adhesion to the substrate.
3. Spraying Parameters: Parameters related to the spraying equipment and
process play a crucial role in coating uniformity and efficiency. These
parameters include spray rate, atomization pressure, nozzle size and design,
spray pattern, and spray angle. Optimal spraying parameters ensure uniform
coverage and distribution of the coating solution over the substrate.
4. Inlet Air Temperature and Relative Humidity: The temperature and
humidity of the air entering the coating chamber influence drying kinetics,
solvent evaporation, and coating film formation. Controlling these parameters
ensures proper drying of the coating solution and prevents defects such as
tackiness, agglomeration, or over-wetting.
5. Coating Pan Rotation Speed: The rotation speed of the coating pan affects the
movement and distribution of tablets or granules within the pan. Proper
agitation promotes uniform coating application, prevents tablet sticking or
clumping, and facilitates drying by exposing all surfaces to the drying air.
6. Drying Time and Temperature: The duration and temperature of the drying
phase influence the drying kinetics and the formation of a solid, uniform coating
 Batch Record Documentation Preparation
film. Drying conditions should be optimized to ensure complete solvent
evaporation without overheating or degradation of the coating material.
7. Process Control and Monitoring: Monitoring and controlling various process
parameters throughout the coating stage are essential for ensuring
reproducibility, quality, and compliance with specifications. This may involve
real-time monitoring of coating thickness, weight gain, appearance, and other
quality attributes using instrumentation and visual inspection.
8. Quality Control Testing: Coated products undergo quality control testing to
assess coating uniformity, thickness, integrity, dissolution profile, and other
performance attributes. Testing methods may include visual inspection, weight
gain measurement, thickness measurement, dissolution testing, and stability
studies.

Blister packing parameters typically refer to various settings and conditions

involved in the process of blister packaging, which is commonly used in
pharmaceuticals, consumer goods, and food industries. These parameters may
include:

1. Material Selection: The choice of materials for the blister (e.g., PVC, PVDC,
PET, etc.) and the backing (e.g., aluminium foil, paper, etc.) based on factors
like product stability, barrier properties, and cost.
2. Formulation: The composition of the product being packed, including its
physical properties such as size, shape, weight, and sensitivity to factors like
moisture, light, and temperature.
3. Sealing Temperature and Pressure: The temperature and pressure applied
during the sealing process to ensure a proper seal between the blister and
backing materials while maintaining product integrity.
 Batch Record Documentation Preparation
4. Sealing Time: The duration for which heat and pressure are applied to ensure
adequate sealing without damaging the product.
5. Cavity Size and Shape: The dimensions and geometry of the blister cavity,
which must accommodate the product securely while allowing easy removal by
the end user.
6. Fill Weight: The amount of product placed into each blister cavity, ensuring
consistency and compliance with regulatory requirements.
7. Printing and Labeling: Parameters related to printing batch numbers, expiry
dates, barcodes, and other essential information on the blister packs.
8. Quality Control: Parameters for inspecting blister packs for defects such as
incomplete seals, improper fill levels, or damaged products.

These parameters may vary depending on the specific requirements of the

product being packaged, regulatory standards, and the capabilities of the blister
packing equipment used. Optimizing these parameters is crucial to ensure the
quality, safety, and efficiency of the blister packing process.